Emergency Use Authorization
Emergency Use Authorization (EUA) information, and list of all current EUAs
В EspaГ±ol
About Emergency Use Authorizations (EUAs)
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs neededВ during public health emergencies.В
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.
Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.
Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. A separate determination and declaration are needed under section 564 of the Federal Food, Drug and Cosmetic Act to enable FDA to issue EUAs, provided other statutory criteria are met.
Information on terminated and revoked EUAs can be found in archived information.
Public Readiness and Emergency Preparedness Act (PREP Act)В
Information on the PREP Act can be found here.
The PREP Act amended the Public Health Service Act (PHS Act) to add section 319F-3 (42 U.S.C. 247d-6d). В The HHS Secretary has issued several Declarations pursuant to section 319F-3 of the PHS Act to provide liability immunity for activities related to medical countermeasures against COVID-19.В
PREP Act - COVID-19 Related Information
- Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
- Amended April 10, 2020 to add countermeasures pursuant to the CARES Act
- COVID-19 - Medical Countermeasures (effective February 4, 2020) Amended April 10, 2020 to add countermeasures pursuant to the CARES Act OGC Advisory Opinion on PREP Act Declaration
- Advisory Opinion 02-02 on the PREP Act and the Secretary's Declaration under the ActВ
- Second Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19
- Third Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19В
Guidance
In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. For more information, please see the January 13, 2017 Federal Register notice.
In addition, in January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.
В
Coronavirus Disease 2019В (COVID-19) EUA Information
- Coronavirus Disease (COVID-19) updates from FDA
- Overviews:
- Detailed Information for all COVID-19 EUAs, including authorizations and fact sheets
In Vitro Diagnostic Products
On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. On the basis of this determination, the Secretary then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19. The EUAs subsequently issued by FDA are listed in the table below this blue box.
In continuing response to the COVID-19 pandemic, on March 24, 2020, and based on the February 4, 2020 HHS EUA determination, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak. EUAs for home collection kits reference this declaration.В
On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during this public health emergency. This guidance was updated on March 16, 2020, May 4, 2020, and May 11, 2020.
CDC has granted a right of reference to the performance data contained in CDC's EUA (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
If you need additional information, please refer to the FAQs on Diagnostic Testing for SARS-CoV-2В and CLIA and University Laboratory Testing FAQ (CMS)
В
| Date EUA First Issued | Most Recent Authorization or Revision | Entity | Diagnostic (Most Recent Letter of Authorization) (PDF) | Product AttributesВ 3, 4 | Authorized Setting(s)В 1 | Authorization LabelingВ 2В (PDF) | Amendments and Other Documents (PDF) | Federal Register Notice for EUA | Other Brand Name(s) |
|---|---|---|---|---|---|---|---|---|---|
| 11/06/2020 | 11/06/2020 | GenScript USA Inc. | cPass SARS-CoV-2 Neutralization Antibody Detection Kit (134KB) | Serology Total Neutralizing Antibodies, Blocking ELISA | H | HCP (151KB) Recipients (138KB) IFU (417KB) |
|
|
None |
| 10/28/2020 | 10/28/2020 | Quansys Biosciences, Inc. | Q-Plex SARS-CoV-2 Human IgG (4 Plex) (140KB) | Serology IgG, CLIA | H | HCP (149KB) Recipients (135KB) IFU (492KB) |
|
|
None |
| 10/28/2020 | 10/28/2020 | DNA Genotek Inc. | ORAcollectв€™RNA OR-100 and ORAcollectв€™RNA ORE-100 saliva collection devices (351KB) | Saliva Collection Device | N/A | EUA Summary (312KB) IFU (670KB) |
|
|
None |
| 10/26/2020 | 10/26/2020 | Agena Bioscience, Inc. | MassARRAY SARS-CoV-2 Panel (119KB) | Molecular RT-PCR, chip array and MALDI-TOF Mass Spec. | H | HCP (155KB) Patients (142KB) IFU (1.43MB) |
|
|
None |
| 10/23/2020 | 10/23/2020 | Celltrion USA, Inc. | Sampinute COVID-19 Antigen MIA (331KB) | Antigen Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA) | H, M | HCP (171KB) Patients (157KB) IFU (5.49MB) |
|
|
None |
| 10/20/2020 | 10/20/2020 | binx health, Inc. | binx health At-Home Nasal Swab COVID-19 Sample Collection Kit (133KB) | Home Collection Kit | N/A | EUA Summary (123KB) IFU (851KB) |
|
|
None |
| 10/15/2020 | 10/15/2020 | Clinical Enterprise, Inc. | EmpowerDX At-Home COVID-19 PCR Test Kit (141KB) | Home Collection Kit | N/A | EUA Summary (145KB) IFU (761KB) |
|
|
None |
| 10/14/2020 | 10/28/2020 | DNA Genotek Inc. | OMNIgeneВ·ORAL OM-505 and OME-505 (OMNIgeneВ·ORAL) saliva collection devices (309KB) (Reissued October 28, 2020)В | Saliva Collection Device | N/A | EUA Summary (596KB) IFU (358KB) |
|
|
None |
| 10/14/2020 | 10/14/2020 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR CompleteВ (145KB) | Molecular RT, qSTAR amplification | H | HCP (153KB) Patients (130KB) IFU (1.75MB) |
|
|
None |
| 10/09/2020 | 10/09/2020 | Abbott Laboratories Inc. | AdviseDx SARS-CoV-2 IgM (210KB) | Serology IgM, CMIA | H, M | HCP (289KB) Recipients (200KB) IFU-ARCHITECT (590KB) IFU-Alinityi (588KB) |
|
|
None |
| 10/08/2020 | 10/13/2020 | Access Bio, Inc. | CareStart COVID-19 Antigen test (327KB) | AntigenВ Lateral Flow, Visual Read | H, M, W | HCP (167KB) Patients (154KB) IFU (1.44MB) |
|
|
None |
| 10/08/2020 | 10/08/2020 | Beckman Coulter, Inc. | Access SARS-CoV-2 IgM (415KB) | Serology IgM, CLIA | H,M | HCP (173KB) Recipients (158KB) IFU (339KB) |
|
|
None |
| 10/08/2020 | 10/08/2020 | Genalyte, Inc. | Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 (326KB) | Serology Total Antibody, photonic ring immunoassay | H, M | HCP (150KB) Recipients (133KB) IFU (358KB) |
|
|
None |
| 10/08/2020 | 10/16/2020 | Spectrum Solutions LLC | SDNA-1000 Saliva Collection Device (302KB) | Saliva Collection Device | N/A | EUA Summary (429KB) IFU (1.57MB) |
|
|
None |
| 10/07/2020 | 10/07/2020 | GenMark Diagnostics, Inc. | ePlex Respiratory Pathogen Panel 2 (331KB) | Molecular RT-PCR and electrochemical detection, Multi-analyte | H, M | HCP (149KB) Patients (137KB) IFU (918KB) |
|
|
None |
| 10/06/2020 | 10/06/2020 | ZEUS Scientific, Inc. | ZEUS ELISA SARS-CoV-2 IgG Test SystemВ (127KB) | Serology IgG, ELISA | H, M | HCP (159KB) Recipients (150KB) IFU (364KB) |
|
|
None |
| 10/06/2020 | 10/08/2020 | University of California, Los Angeles (UCLA) | UCLA SwabSeq COVID-19 Diagnostic Platform (297KB)В | Molecular RT-PCR and Sequencing | H | HCP (163KB) Patients (150KB) EUA Summary (160KB) |
|
|
None |
| 10/05/2020 | 10/05/2020 | SEASUN BIOMATERIALS, Inc. | AQ-TOP COVID-19 Rapid Detection Kit PLUS (145KB) | Molecular RT-LAMP | H | HCP (157KB) Patients (144KB) IFU (802KB) |
|
|
None |
| 10/02/2020 | 10/02/2020 | Quidel Corporation | Sofia 2 Flu + SARS Antigen FIA (147KB) | Antigen Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte | H, M, W | HCP (164KB) Patients (149KB) IFU (1.83MB) |
|
|
None |
| 10/02/2020 | 10/06/2020 | Thermo Fisher Scientific | OmniPATH COVID-19 Total Antibody ELISA Test (176KB) | Serology Total Antibody, ELISA | H, M | HCP (156KB) Recipients (143KB) IFU (354KB) |
|
|
None |
| 10/02/2020 | 10/02/2020 | BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (151KB) | Molecular RT, Nested multiplex PCR, Multi-analyte | H, M, W | HCP (158KB) Patients (144KB) IFU (5.26MB) |
|
|
None |
| 10/01/2020 | 10/01/2020 | UMass Memorial Medical Center | UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel (105KB) | Molecular Real-time RT-PCR | H | HCP (120KB) Patients (108KB) EUA Summary (468KB) |
|
|
None |
| 10/01/2020 | 10/01/2020 | Beckman Coulter, Inc. | Access IL-6 (297KB) | One-step immunoenzymatic ("sandwich") assay, IL-6 | H, M | HCP (83KB) Patients (72KB) IFU (368KB) |
|
|
None |
| 10/01/2020 | 10/01/2020 | Tempus Labs, Inc. | iC SARS-CoV2 Test (292KB) | MolecularВ Real-time RT-PCR | H | HCP (138KB) Patients (125KB) EUA Summary (583KB) |
|
|
None |
| 09/30/2020 | 09/30/2020 | Alimetrix, Inc. | Alimetrix SARS-CoV-2 RT-PCR Assay (284KB) | Molecular RT-PCR, Microarray Hybridization | H | HCP (108KB) Patients (97KB) EUA Summary (980KB) |
|
|
None |
| 09/29/2020 | 09/29/2020 | DiaSorin, Inc. | DiaSorin LIAISON SARS-CoV-2 IgM Assay (124KB) | Serology Real-time RT-PCR | H | HCP (155KB) Recipients (141KB) IFU (309KB) |
|
|
None |
| 09/29/2020 | 09/29/2020 | NanoEntek America, Inc. | FREND COVID-19 total Ab (126KB) | Serology Total Antibody, FIA | H, M | HCP (156KB) Recipients (147KB) IFU (439KB) |
|
|
None |
| 09/29/2020 | 09/29/2020 | Nirmidas Biotech, Inc. | Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit (150KB) | Serology Total Antibody, FIA | H, MВ | HCP (162KB) Recipients (149KB) IFU (215KB) |
|
|
None |
| 09/30/2020 | 09/30/2020 | Aeon Global Health | Aeon Global Health SARS-CoV-2 Assay (111KB) | Molecular Real-time RT-PCR | H | HCP (119KB) Patients (108KB) EUA Summary (167KB) |
|
|
None |
| 09/29/2020 | 09/29/2020 | CENTOGENE US, LLC | CentoSure SARS-CoV-2 RT-PCR Assay (112KB) | Molecular Real-time RT-PCR, Screening | H | HCP (154KB) Patients (145KB) EUA Summary (170KB) |
|
|
None |
| 09/29/2020 | 09/29/2020 | Akron Children’s Hospital | Akron Children’s Hospital SARS-CoV-2 Assay (128KB) | Molecular Real-time RT-PCR | H | HCP (119KB) Patients (108KB) EUA Summary (183KB) |
|
|
None |
| 09/29/2020 | 09/29/2020 | National Jewish Health | SARS-CoV-2 MassArray Test (112KB) | Molecular RT-PCR and MALDI-TOF Mass Spec. | H | HCP (119KB) Patients (107KB) EUA Summary (170KB) |
|
|
None |
| 09/25/2020 | 10/17/2020 | Genetrack Biolabs, Inc. | Genetrack SARS-CoV-2 Molecular Assay (292KB) | Molecular Real-time RT-PCR, Home Collection | H | HCP (147KB) Patients (133KB) EUA Summary (497KB) IFU (Home Collect) (442KB) |
|
None | |
| 09/25/2020 | 09/25/2020 | Quotient Suisse SA | MosaiQ COVID-19 Antibody Magazine (372KB) | Serology Total Antibody, photometric immunoassay | H | HCP (149KB) Recipients (132KB) IFU (53.04MB) |
|
|
None |
| 09/24/2020 | 10/01/2020 | Cepheid | Xpert Xpress SARS-CoV-2/Flu/RSV 09/24/2020В (303KB) (Reissued October 1, 2020) | Molecular Real-time RT-PCR, Multi-analyte | H, M, W | HCP (153KB) Patients (135KB) IFU for Labs (558KB) IFU for Point-of-CareВ (2.20MB) |
|
|
None |
| 09/23/2020 | 09/23/2020 | Clear Labs, Inc. | Clear Dx SARS-CoV-2 Test 09/23/2020 (132KB) | Molecular RT-PCR and Sequencing | H | HCP (137KB) Patients (125KB) IFU (1.7MB) |
|
|
None |
| 09/23/2020 | 09/23/2020 | Jiangsu Well Biotech Co., Ltd. | Orawell IgM/IgG Rapid Test 09/23/2020 (130KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (146KB) Recipient (130KB) IFU (306KB) |
|
|
None |
| 09/22/2020 | 09/22/2020 | Quadrant Biosciences Inc. | Clarifi COVID-19 Test Kit 09/22/2020В (146KB) | Molecular Real-time RT-PCR, Saliva | H | HCPВ (152KB) PatientsВ (138KB) IFUВ (325KB) |
|
|
None |
| 09/22/2020 | 09/22/2020 | Vela Operations Singapore Pte. Ltd. | ViroKey SARS-CoV-2 RT-PCR Test v2.0 09/22/2020В (143KB) | Molecular Real-time RT-PCR | H | HCPВ (156KB) PatientsВ (144KB0 IFUВ (3.3MB) |
|
|
None |
| 09/21/2020 | 09/21/2020 | KimForest Enterprise Co., Ltd. | KimForest SARS-CoV-2 Detection Kit v1 (143KB) | Molecular Real-time RT-PCR | H | HCP (155KB) Patients (152KB) IFU (1.43MB) |
|
|
None |
| 09/18/2020 | 09/18/2020 | GK Pharmaceuticals Contract Manufacturing Operations | GK ACCU-RIGHT SARS-CoV-2 RT-PCR KITВ (320KB) | Molecular Real-time RT-PCR | H | HCPВ (154KB) PatientsВ (145KB) IFUВ (707KB) |
|
|
None |
| 09/16/2020 | 09/16/2020 | Visby Medical, Inc. | Visby Medical COVID-19 (144KB) | Molecular RT-PCR | H, M | HCP (150KB) Patients (138KB) IFU (5.97MB) |
|
|
None |
| 09/14/2020 | 09/14/2020 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MAGLUMI 2019-nCoV IgM/IgG (128KB) | Serology IgM and IgG, CLIA | H, M | HCP (160KB) Recipients (153KB) IFU (9.23MB) |
|
|
None |
| 09/14/2020 | 09/18/2020 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (151KB) | Molecular Real-time RT-PCR, Multi-analyte | H, M, W | HCP (179KB) Patients (154KB) IFU (3.67MB) |
|
None | |
| 09/09/2020 | 09/09/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgM Antibody Test Kit (159KB) | Serology IgM, CLIA | H, M | HCP (151KB) Recipients (148KB) IFU (2.02MB) |
|
|
None |
| 09/09/2020 | 09/09/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgG Antibody Test Kit (159KB) | Serology IgG, CLIA | H, M | HCP (157KB) Recipients (148KB) IFU (2.02MB) |
|
|
None |
| 09/09/2020 | 10/31/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Wantai SARS-CoV-2 RT-PCR Kit (137KB) | MolecularВ Real-time RT-PCR | H | HCP (158KB) Patients (141KB) IFU (720KB) |
|
None | |
| 04/23/2020 | 04/23/2020 | SD Biosensor, Inc. | STANDARD M nCoV Real-Time Detection Kit (129KB) | MolecularВ Real-time RT-PCR | H | HCP (136KB) Patients (124KB) IFU (548KB) |
|
None | |
| 02/04/2020 | 07/13/2020 | CDC | CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (286KB) (Reiussed March 15, 2020) | MolecularВ Real-time RT-PCR | H | HCP (137KB) Patients (124KB) IFU (1.18MB) |
None | ||
| 02/29/2020 | 03/15/2020 | Wadsworth Center, New York State Department of Health's (CDC) | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (312KB) (Reissued 03/10/2020) | MolecularВ Real-time RT-PCR | H | HCP (140KB) Patients (117KB) IFU (314KB) |
None | ||
| 03/12/2020 | 05/13/2020 | Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2 (149KB) (Reissued October 15, 2020) | MolecularВ Real-time RT-PCR, Pooling | H, M | HCP (145KB) Patients (133KB) IFU (1.45MB) |
None | ||
| 03/13/2020 | 10/16/2020 | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit (386KB) (Reissued October 9, 2020) | MolecularВ Real-time RT-PCR, Home Collection | H | HCP (180KB) Patients (168KB) IFU (3.52MB) |
None | ||
| 03/16/2020 | 09/23/2020 | Hologic, Inc. | Panther Fusion SARS-CoV-2 Assay (149KB) (Reissued September 23, 2020) | Molecular Real-time RT-PCR, Pooling, Screening | H | HCP (154KB) Patients (141KB) IFU (1.15MB) |
None | ||
| 03/16/2020 | 11/04/2020 | Laboratory Corporation of America (LabCorp) | COVID-19 RT-PCR Test (417KB) (Reissued September 18, 2020) | Molecular Real-time RT-PCR, Home Collection, Pooling, Screening | H | HCP (107KB) Patients (94KB) EUA Summary (1.08MB) IFU - Pixel Home CollectВ (1.19MB) IFU - LabCorp Home Collect (150KB) |
None | ||
| 03/17/2020 | 04/08/2020 | Quidel Corporation | Lyra SARS-CoV-2 Assay (294KB) | MolecularВ Real-time RT-PCR | H | HCP (133KB) Patients (121KB) IFU (479KB) |
None | ||
| 03/17/2020 | 09/21/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest SARS-CoV-2 rRT-PCR (151KB) (reissued August 7, 2020) | Molecular Real-time RT-PCR, Home Collection, Pooling | H | HCP (153KB) Patients (139KB) IFU (340KB) IFU (Home Collect) (627KB) |
|
None | |
| 03/18/2020 | 07/30/2020 | Abbott Molecular | Abbott RealTime SARS-CoV-2 assay (324KB) | Molecular Real-time RT-PCR | H | HCP (162KB) Patients (150KB) IFU (408KB) |
None | ||
| 03/19/2020 | 06/04/2020 | DiaSorin Molecular LLC | Simplexa COVID-19 Direct (103KB) | MolecularВ Real-time RT-PCR | H, M | HCP (136KB) Patients (125KB) IFU (622KB) |
None | ||
| 03/19/2020 | 08/18/2020 | GenMark Diagnostics, Inc. | ePlex SARS-CoV-2 Test (126KB) | MolecularВ RT-PCR and electrochemical detection | H, M | HCP (159KB) Patients (145KB) IFU (468KB) |
None | ||
| 03/20/2020 | 04/08/2020 | Primerdesign Ltd | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (132KB) | MolecularВ Real-time RT-PCR | H | HCP (137KB) Patients (125KB) IFU (1,013KB) |
None | ||
| 03/20/2020 | 09/21/2020 | Cepheid | Xpert Xpress SARS-CoV-2 test (140 KB) | MolecularВ Real-time RT-PCR | H, M, W | HCP (151KB) Patients (137KB) IFU - Laboratories (391KB) IFU - Point of Care (1.10MB) |
|
None | |
| 03/23/2020 | 04/30/2020 | BioFire Defense, LLC | BioFire COVID-19 Test (317 KB) | MolecularВ RT, Nested multiplex PCR | H, M | HCP (135KB) Patients (123KB) IFU (3.44MB) |
None | ||
| 03/23/2020 | 08/24/2020 | Mesa Biotech Inc. | Accula SARS-Cov-2 Test (322 KB) | MolecularВ RT and amplification | H, M, W | HCP (140KB) Patients (127KB) IFU (2.46MB) |
None | ||
| 03/24/2020 | 10/28/2020 | PerkinElmer, Inc. | PerkinElmer New Coronavirus Nucleic Acid Detection Kit (146 KB) (Reissued October 28, 2020) | MolecularВ Real-time RT-PCR, Pooling | H | HCP (149KB) Patients (137KB) IFU (648KB) |
None | ||
| 03/25/2020 | 09/25/2020 | Avellino Lab USA, Inc. | AvellinoCoV2 test (284KB) | MolecularВ Real-time RT-PCR | H | HCP (139KB) Patients (120KB) EUA Summary (420KB) |
|
None | |
| 03/26/2020 | 04/24/2020 | BGI Genomics Co. Ltd | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (131KB) | MolecularВ Real-time RT-PCR | H | HCP (163KB) Patients (151KB) IFU (461KB) |
None | ||
| 03/27/2020 | 09/17/2020 | Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 (174KB) (Reissued September 17, 2020) | Molecular RT, Isothermal amplification | H, M, W | HCP (156KB) Patients (142KB) IFU (2.84MB) |
None | ||
| 03/27/2020 | 10/28/2020 | Luminex Molecular Diagnostics, Inc. | NxTAG CoV Extended Panel Assay (318KB) | MolecularВ RT-PCR | H | HCP (136KB) Patients (123KB) IFU (1.02MB) |
|
None | |
| 03/30/2020 | 04/23/2020 | NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay (127KB) | MolecularВ RT-PCR | H, M | HCP (135KB) Patients (124KB) IFU (441KB) |
None | ||
| 03/30/2020 | 09/21/2020 | QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel (128KB) | Molecular Real-time RT-PCR, Multi-analyte | H, M | HCP (140KB) Patients (124KB) IFU (1.93MB) |
|
None | |
| 04/01/2020 | 06/12/2020 | Cellex Inc. | qSARS-CoV-2 IgG/IgM Rapid Test (144KB) (Reissued June 12, 2020) | Serology IgM and IgG, Lateral Flow | H, M | HCP (138KB) Patients (126KB) IFU (326KB) |
|
None | |
| 04/01/2020 | 04/01/2020 | Ipsum Diagnostics, LLC | COV-19 IDx assay (288KB) | MolecularВ Real-time RT-PCR | H | HCP (133KB) Patients (121KB) EUA Summary (130KB) |
|
None | |
| 04/02/2020 | 09/22/2020 | Becton, Dickinson & Company (BD) | BioGX SARS-CoV-2 Reagents for BD MAX System (154KB) | Molecular | H, M | HCP (139KB) Patients (127KB) IFU (3.55MB) |
None | ||
| 04/03/2020 | 10/28/2020 | Luminex Corporation | ARIES SARS-CoV-2 Assay (125KB) | MolecularВ RT-PCR | H, M | HCP (138KB) Patients (124KB) IFU (5.22MB) |
None | ||
| 04/03/2020 | 09/22/2020 | ScienCell Research Laboratories | ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (319KB) | MolecularВ Real-time RT-PCR | H | HCP (164KB) Patients (151KB) IFU (505KB) |
None | ||
| 04/03/2020 | 04/03/2020 | Co-Diagnostics, Inc. | Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (317KB) | MolecularВ RT-PCR, CoPrimer technology | H | HCP (135KB) Patients (123KB) IFU (476KB) |
|
None | |
| 04/06/2020 | 04/28/2020 | Gnomegen LLC | Gnomegen COVID-19 RT-Digital PCR Detection Kit (320KB) | MolecularВ Real-time RT-digital PCR | H | HCP (135KB) Patients (123KB) IFU (227KB) |
|
None | |
| 04/07/2020 | 10/02/2020 | InBios International, Inc. | Smart Detect SARS-CoV-2 rRT-PCR Kit (128KB) | MolecularВ Real-time RT-PCR | H | HCP (176KB) Patients (164KB) IFU (1.27MB) |
None | ||
| 04/08/2020 | 09/23/2020 | Becton, Dickinson & Company | BD SARS-CoV-2Reagents for BD MAX System (155KB) (Reissued September 23, 2020) | MolecularВ Real-time RT-PCR | H, M | HCP (149KB) Patients (138KB) IFU (2.97MB) |
None | ||
| 04/08/2020 | 10/26/2020 | DiaCarta, Inc. | QuantiVirus SARS-CoV-2 Test kit (145KB) (Reissued October 26, 2020) | MolecularВ Real-time RT-PCR | H | HCP (156KB) Patients (143KB) IFU (2.03MB) |
|
None | |
| 04/10/2020 | 07/18/2020 | Atila BioSystems, Inc. | iAMP COVID-19 Detection Kit (124KB) | MolecularВ RT, Isothermal amplification | H | HCP (137KB) Patients (124KB) IFU (1.01MB) |
None | ||
| 04/14/2020 | 10/30/2020 | Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (379KB) | Serology Total Antibody, CLIA | H, M | HCP (158KB) Recipients (145KB) IFU (329KB) |
None | ||
| 04/15/2020 | 04/15/2020 | Maccura Biotechnology (USA) LLC | SARS-CoV-2 Fluorescent PCR Kit (154KB) | MolecularВ Real-time RT-PCR | H | HCP (252KB) Patients (191KB) IFU (1.13MB) |
None | ||
| 04/15/2020 | 04/15/2020 | Mount Sinai Laboratory | COVID-19 ELISA IgG Antibody Test (339KB) | Serology IgG, ELISA | H | HCP (334KB) Patients (256KB) EUA Summary (301KB) |
|
None | |
| 04/16/2020 | 04/16/2020 | GenoSensor, LLC | GS COVID-19 RT-PCR KIT (317KB) | MolecularВ Real-time RT-PCR | H | HCP (133KB) Patients (121KB) IFU (408KB) |
|
None | |
| 04/16/2020 | 06/11/2020 | KorvaLabs Inc. | Curative-Korva SARS-Cov-2 Assay (280KB) | MolecularВ Real-time RT-PCR | H | HCP (136KB) Patients (124KB) EUA Summary (107KB) |
None | ||
| 04/17/2020 | 04/17/2020 | Fosun Pharma USA Inc. | Fosun COVID-19 RT-PCR Detection Kit (317KB) | MolecularВ Real-time RT-PCR | H | HCP (249KB) Patients (190KB) IFU (860KB) |
|
None | |
| 04/18/2020 | 04/18/2020 | OSANG Healthcare | GeneFinder COVID-19 Plus RealAmp Kit (320KB) | MolecularВ Real-time RT-PCR | H | HCP (137KB) Patients (125KB) IFU (494KB) |
|
None | |
| 04/20/2020 | 08/08/2020 | Trax Management Services Inc. | PhoenixDx 2019-CoV (134KB) | MolecularВ Real-time RT-PCR | H | HCP (196KB) Patients (163KB) IFU (505KB) |
None | ||
| 04/21/2020 | 11/02/2020 | Seegene, Inc. | Allplex 2019-nCoV Assay (124KB) | MolecularВ Real-time RT-PCR | H | HCP (138KB) Patients (125KB) IFU (3.58MB) |
None | ||
| 04/22/2020 | 04/22/2020 | altona Diagnostics GmbH | RealStar SARS-CoV02 RT-PCR Kits U.S. (130KB) | MolecularВ Real-time RT-PCR | H | HCP (138KB) Patients (126KB) IFU (566KB) |
|
None | |
| 04/24/2020 | 10/19/2020 | DiaSorin Inc. | LIAISON SARS-CoV-2 S1/S2 IgG (368KB) | Serology IgG, CLIA | H, M | HCP (149KB) Recipients (135KB) IFU (325KB) |
None | ||
| 04/24/2020 | 10/23/2020 | Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (370KB) | Serology IgG, CLIA | H, M | HCP (159KB) Recipients (145KB) IFU (326KB) |
None | ||
| 04/27/2020 | 09/01/2020 | SEASUN BIOMATERIALS | U-TOP COVID-19 Detection KitВ (129KB) | MolecularВ Real-time RT-PCR | H | HCP (153KB) Patients (141KB) IFU (1.05MB) |
None | ||
| 04/26/2020 | 09/18/2020 | Abbott Laboratories Inc. | SARS-CoV-2 IgG assay (367KB) | Serology IgG, CMIA | H, M | HCP (112KB) Recipients (127KB) IFU-ARCHITECT (2.72MB) IFU-Alinityi (2.57MB) |
None | ||
| 04/29/2020 | 09/22/2020 | LabGenomics Co., Ltd. | LabGun COVID-19 RT-PCR Kit (134KB) | MolecularВ Real-time RT-PCR | H | HCP (109KB) Patients (98KB) IFU (1.35MB) |
|
None | |
| 04/29/2020 | 09/21/2020 | Rheonix, Inc. | Rheonix COVID-19 MDx Assay (133KB) | MolecularВ RT-PCR | H | HCP (107KB) Patients (97KB) IFU (4.44MB) |
|
None | |
| 04/29/2020 | 10/30/2020 | Bio-Rad Laboratories | Platelia SARS-CoV-2 Total Ab assay (141KB) | Serology Total Antibody, ELISA | H | HCP (146KB) Recipients (132KB) IFU (304KB) |
None | ||
| 04/30/2020 | 04/30/2020 | Wadsworth Center, New York State Department of Health | New York SARS-CoV Microsphere Immunoassay for Antibody Detection (115KB) | Serology Total Antibody, FMIA | H | HCP (158KB) Recipients (140KB) EUA Summary (92KB) |
|
None | |
| 05/01/2020 | 09/18/2020 | Bio-Rad Laboratories, Inc. | Bio-Rad SARS-CoV-2 ddPCR Test (320KB) (Reissued September 18, 2020) | MolecularВ RT-droplet PCR | H | HCP (141KB) Patients (129KB) IFU (1.76MB) |
|
None | |
| 05/01/2020 | 05/01/2020 | BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1 (RP2.1) (400KB) | Molecular, RT, Nested multiplex PCR, Multi-analyte | H, M | HCP (139KB) Patients (126KB) IFU (1.24MB) |
|
None | |
| 05/02/2020 | 10/23/2020 | Roche Diagnostics | Elecsys Anti-SARS-CoV-2 (302KB) | Serology Total Antibody, ECLIA | H, M | HCP (147KB) Recipients (133KB) IFU (163KB) |
None | ||
| 05/04/2020 | 05/04/2020 | EUROIMMUN US Inc. | Anti-SARS-CoV-2 ELISA (IgG) (333KB) | Serology IgG, ELISA | H | HCP (42KB) Recipients (51KB) IFU (241KB) |
|
None | |
| 05/04/2020 | 05/04/2020 | Sansure BioTech Inc.В | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (360KB) | MolecularВ Real-time RT-PCR | H | HCP (212KB) Patients (171KB) IFU (988KB) |
|
None | |
| 05/05/2020 | 07/09/2020 | Fast Track Diagnostics Luxembourg S.ГЎ.r.l. (a Siemens Healthineers Company) | FTD SARS-CoV-2 (300KB) | MolecularВ Real-time RT-PCR | H | HCP (141KB) Patients (129KB) IFU (2.10MB) |
None | ||
| 05/06/2020 | 07/29/2020 | OPTI Medical Systems, Inc. | OPTI SARS-CoV-2 RT PCR Test (396KB) | MolecularВ Real-time RT-PCR | H | HCP (312KB) Patients (231KB) IFU (388KB) |
None | ||
| 05/06/2020 | 09/21/2020 | Sherlock BioSciences, Inc. | Sherlock CRISPR SARS-CoV-2 Kit (397KB) | MolecularВ RT-LAMP, CRISPR | H | HCP (250KB) Patients (190KB) IFU (538KB) |
|
None | |
| 05/06/2020 | 11/06/2020 | BioMГ©rieux SA | SARS-COV-2 R-GENE (422KB) | MolecularВ Real-time RT-PCR | H | HCP (174KB) Patients (131KB) IFU (727KB) |
None | ||
| 05/07/2020 | 05/28/2020 | Zymo Research Corporation | Quick SARS-CoV-2rRT-PCR KitВ (396KB) | MolecularВ Real-time RT-PCR | H | HCPВ (289KB) PatientsВ (245KB) IFUВ (641KB) |
None | ||
| 04/10/2020 | 09/18/2020 | Infinity BiologiX LLC | Infinity BiologiX TaqPath SARS-CoV-2 Assay 04/10/2020В (317KB) (reissued September 18, 2020) |
Molecular Real-time RT-PCR, Home Collection | H | HCPВ (145KB) PatientsВ (132KB) IFUВ (591KB) EUA SummaryВ (622KB) |
|
None | |
| 05/08/2020 | 07/17/2020 | Quidel Corporation | Sofia 2 SARS Antigen FIAВ (138KB) | AntigenВ Lateral Flow, Fluorescence, Instrument Read | H, M, W | HCPВ (152KB) PatientsВ (136KB) IFUВ (2.39MB) |
None | ||
| 05/08/2020 | 05/08/2020 | Gnomegen LLC | Gnomegen COVID-19-RT-qPCR Detection Kit (314KB) | MolecularВ Real-time RT-PCR | H | HCPВ (135KB) PatientsВ (123KB) IFU (1.36MB) |
|
None | |
| 05/11/2020 | 05/11/2020 | 1drop Inc. | 1copy COVID-19 qPCR Multi Kit (395KB) | Molecular Real-time, RT-PCR | H | HCP (347KB) Patients (264KB) IFU (2.61MB) |
|
None |
|
| 05/11/2020 | 08/24/2020 | Abbott Molecular Inc. | Alinity m SARS-CoV-2 assay (394KB) | Molecular Real-time RT-PCR | H, M | HCP (142KB) Patients (130KB) IFU (582KB) |
None | ||
| 05/13/2020 | 09/21/2020 | Applied DNA Sciences, Inc. | Linea COVID-19 Assay Kit (393KB) | MolecularВ Real-time RT-PCR | H | HCP (138KB) Patients (125KB) IFU (263KB) |
|
None | |
| 05/14/2020 | 10/05/2020 | Hologic, Inc. | Aptima SARS-CoV-2 assay (153KB) (Reissued October 5, 2020) | MolecularВ TMA, chemiluminescent, Pooling, Screening | H | HCP (157KB) Patients (143KB) IFU (330KB) |
None | ||
| 05/14/2020 | 09/21/2020 | GeneMatrix, Inc. | NeoPlex COVID-19 Detection Kit (135KB) | MolecularВ Real-time RT-PCR | H | HCP (139KB) Patients (98KB) IFU (1.09MB) |
|
None | |
| 05/15/2020 | 09/04/2020 | Everlywell, Inc. | Everlywell COVID-19 Test Home Collection Kit (307KB) | Home Collection Kit | N/A | IFU (624KB) EUA Summary (152KB) |
None | ||
| 05/15/2020 | 06/15/2020 | Fulgent Therapeutics, LLC | Fulgent COVID-19 by RT-PCR Test (288KB) | Molecular Real-time RT-PCR, Home Collection | H | HCP (138KB) Patients (126KB) EUA Summary (188KB) IFU (Home Collect) (273KB) |
None | ||
| 05/15/2020 | 09/21/2020 | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel (116KB) (Reissued August 19, 2020) | Molecular, Real-time RT-PCR, Home Collection | H | HCP (154KB) Patients (142KB) EUA Summary (372KB) IFU (Home Collect) (232KB) |
|
None | |
| 05/18/2020 | 05/18/2020 | Quidel Corporation | Lyra Direct SARS-CoV-2 Assay (396KB) | MolecularВ Real-time RT-PCR | H | HCP (250KB) Patients (190KB) IFU (596KB) |
|
|
None |
| 05/21/2020 | 09/21/2020 | BioCore Co., Ltd. | BioCore 2019-nCoV Real Time PCR Kit (415KB) | MolecularВ Real-time RT-PCR | H | HCP (252KB) Patients (190KB) IFU (1.88MB) |
|
|
None |
| 05/21/2020 | 05/21/2020 | SolGent Co., Ltd. | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (393KB) | MolecularВ Real-time RT-PCR | H | HCP (250KB) Patients (209KB) IFU (2.06MB) |
|
|
None |
| 05/21/2020 | 05/21/2020 | Seasun Biomaterials, Inc. | AQ-TOP COVID-19 Rapid Detection Kit (395KB) | MolecularВ RT-LAMP, CRISPR | H | HCP (254KB) Patients (192KB) IFU (1.02MB) |
|
|
None |
| 05/21/2020 | 10/20/2020 | P23 Labs, LLC. | P23 Labs TaqPath SARS-CoV-2 Assay (160KB) (Reissued October 20, 2020) | Molecular Real-time RT-PCR, Home Collection, Saliva | H | HCP (156KB) Patients (142KB) IFU1- Home Collect (997KB) IFU2 (Home Collect) (1.38MB) EUA Summary (290KB) |
|
None | |
| 05/22/2020 | 08/11/2020 | dba SpectronRx | Hymon SARS-CoV-2 Test Kit (133KB) | MolecularВ Real-time RT-PCR | H | HCP (153KB) Patients (97KB) IFU (283KB) |
|
None | |
| 05/22/2020 | 09/21/2020 | Exact Sciences Laboratories | SARS-CoV-2 (N gene detection) Test (126KB) (Reissued August 3, 2020) | Molecular Real-time RT-PCR, Home Collection | H | HCP (160KB) Patients (140KB) EUA Summary (597KB) IFU (Home Collect) (361KB) |
|
|
None |
| 05/28/2020 | 10/28/2020 | PrivaPath Diagnostics, Inc. | LetsGetChecked Coronavirus (COVID-19) Test (116KB) (Reissued August 14, 2020) | Molecular TMA, chemiluminescent, Home Collection | H | HCP (158KB) Patients (144KB) IFU- Home Collect (459KB) EUA Summary (126KB) |
|
None | |
| 05/29/2020 | 05/29/2020 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur SARS-CoV-2 Total (COV2T) (337KB) | Total Antibody, CLIA | H, M | HCP (80KB) Recipients (136KB) IFU (1.08MB) |
|
|
None |
| 05/29/2020 | 05/29/2020 | Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 Total (COV2T) (339KB) | Total Antibody, CLIA | H, M | HCP (80KB) Recipients (135KB) IFU (1.06MB) |
|
|
None |
| 05/29/2020 | 05/29/2020 | Healgen Scientific LLC | COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (298KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (81KB) Recipients (134KB) IFU (361KB) |
|
|
None |
| 06/01/2020 | 09/21/2020 | Gravity Diagnostics, LLC | Gravity Diagnostics COVID-19 Assay (370KB) | Molecular Real-time RT-PCR, Home Collection | H | HCP (250KB) Patients (188KB) EUA Summary (135KB) |
|
|
None |
| 06/02/2020 | 06/02/2020 | Roche Diagnostics | Elecsys IL-6 (369KB) | Immunoassay-IL-6 | H, M | HCP (193KB) Patients (146KB) IFU (178KB) |
|
|
None |
| 06/04/2020 | 06/04/2020 | Vibrant America Clinical Labs | Vibrant COVID-19 Ab Assay (284KB) | Serology IgM and IgG, CLIA | H | HCP (137KB) Recipients (193KB) EUA Summary (157KB) |
|
|
None |
| 06/04/2020 | 06/04/2020 | Phosphorus Diagnostics LLC | Phosphorus COVID-19 RT-qPCR Test (267KB) | Molecular Real-time RT-PCR, Home Collection, Saliva | H | HCP (141KB) Patients (128KB) EUA Summary (355KB) IFU (Home Collect) (2.90MB) IFU (Clinic) (279KB) |
|
None | |
| 06/04/2020 | 08/31/2020 | Hangzhou Biotest Biotech Co., Ltd. | RightSign COVID-19 IgG/IgM Rapid Test Cassette (336KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (82KB) Recipients (133KB) IFU (616KB) |
|
Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette CoronaCHEK COVID-19 IgG/IgM Rapid Test Cassette |
|
| 06/05/2020 | 06/05/2020 | Genetron Health (Beijing) Co., Ltd. | Genetron SARS-CoV-2 RNA Test (320KB) | MolecularВ Real-time RT-PCR | H | HCP (157KB) Patients (124KB) IFU (300KB) |
|
|
None |
| 06/08/2020 | 11/04/2020 | Euroimmun US Inc. | EURORealTime SARS-CoV-2 (138KB) | MolecularВ Real-time RT-PCR | H | HCP (196KB) Patients (KB) IFU (290KB) |
|
|
None |
| 06/08/2020 | 10/30/2020 | Siemens Healthcare Diagnostics Inc. | Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) (248KB) | Total Antibody, CLIA | H, M | HCP (154KB) Recipients (140KB) IFU (1.59MB) |
|
None | |
| 06/08/2020 | 10/30/2020 | Siemens Healthcare Diagnostics Inc. | Dimension Vista SARS-CoV-2 Total antibody assay (COV2T) (248KB) | Total Antibody, CLIA | H, M | HCP (154KB) Recipients (141KB) IFU (1.59MB) |
|
None | |
| 06/09/2020 | 10/28/2020 | Illumina, Inc. | Illumina COVIDSeq Test (128KB) | Molecular | H | HCP (131KB) Patients (116KB) IFU (330KB) |
|
None | |
| 06/09/2020 | 09/21/2020 | ChromaCode Inc. | HDPCR SARS-CoV-2 Assay (122KB) | MolecularВ Real-time RT-PCR | H | HCP (134KB) Patients (121KB) IFU (2.46MB) |
|
|
None |
| 06/10/2020 | 08/20/2020 | Cue Health Inc. | Cue COVID-19 Test (144KB) | MolecularВ RT, Isothermal amplification | H, M, W | HCP (144KB) Patients (132KB) IFU (6.32MB) |
|
None | |
| 06/10/2020 | 06/10/2020 | TBG Biotechnology Corp. | ExProbe SARS-CoV-2 Testing Kit (142KB) | MolecularВ Real-time RT-PCR | H | HCP (149KB) Patients (137KB) IFU (420KB) |
|
|
None |
| 06/10/2020 | 06/10/2020 | Tide Laboratories, LLC | DTPM COVID-19 RT-PCR Test (136KB) | MolecularВ Real-time RT-PCR | H | HCP (146KB) Patients (134KB) EUA Summary (170KB) |
|
|
None |
| 06/10/2020 | 06/10/2020 | InBios International, Inc. | SCoV-2 Detect IgG ELISA (107KB) | Serology IgG, ELISA | H | HCP (242KB) Recipients (165KB) IFU (450KB) |
|
|
None |
| 06/12/2020 | 06/12/2020 | RTA Laboratories Biological Products Pharmaceutical and Machinery Industry | Diagnovital SARS-CoV-2 Real-Time PCR Kit (149KB) | MolecularВ Real-time RT-PCR | H | HCP (149KB) Patients (135KB) IFU (446KB) |
|
|
None |
| 06/13/2020 | 09/09/2020 | Kaiser Permanente Mid-Atlantic States | KPMAS COVID-19 Test (116KB) (Reissued September 9, 2020) | Molecular Real-time RT-PCR, Home Collection, Screening | H | HCP (156KB) Patients (144KB) EUA Summary (170KB) IFU (Home Collect) (501KB) |
|
|
None |
| 06/15/2020 | 10/22/2020 | Applied BioCode, Inc. | BioCode SARS-CoV-2 Assay (226KB) | Molecular RT-PCR | H | HCP (148KB) Patients (136KB) IFU (518KB) |
|
None | |
| 06/15/2020 | 06/15/2020 | Emory Medical Laboratories | SARS-CoV-2 RBD IgG test (103KB) | Serology IgG, ELISA | H | HCP (83KB) Recipients (143KB) EUA Summary (99KB) |
|
|
None |
| 06/17/2020 | 06/17/2020 | Omnipathology Solutions Medical Corporation | Omni COVID-19 Assay by RT-PCR (115KB) | MolecularВ Real-time RT-PCR | H | HCP (115KB) Patients (104KB) EUA Summary (167KB) |
|
|
None |
| 06/17/2020 | 06/17/2020 | The Ohio State University Wexner Medical Center | OSUWMC COVID-19 RT-PCR test (114KB) | MolecularВ Real-time RT-PCR | H | HCP (116KB) Patients (104KB) EUA Summary (158KB) |
|
|
None |
| 06/18/2020 | 07/21/2020 | 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. | TRUPCR SARS-CoV-2 Kit (229KB) | Molecular Real-time RT-PCR | H | HCP (145KB) Patients (133KB) IFU (631KB) |
|
None | |
| 06/18/2020 | 06/18/2020 | Jiangsu Bioperfectus Technologies Co., Ltd. | COVID-19 Coronavirus Real Time PCR Kit (144KB) | MolecularВ Real-time RT-PCR | H | HCP (155KB) Patients (149KB) IFU (1.16MB) |
|
|
None |
| 06/18/2020 | 10/17/2020 | Biohit Healthcare (Hefei) Co. Ltd. | Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit (345KB) | Serology IgM and IgG Lateral Flow | H, M | HCP (98KB) Recipients (150KB) IFU (555KB) |
|
ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit | |
| 06/19/2020 | 08/12/2020 | Hangzhou Laihe Biotech Co., Ltd. | LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) (311KB) | Serology IgM and IgG Lateral Flow | H, M | HCP (158KB) Recipients (139KB) IFU (1.17MB) |
|
None | |
| 06/23/2020 | 06/23/2020 | Gencurix, Inc. | GenePro SARS-CoV-2 Test (134KB) | MolecularВ Real-time RT-PCR | H | HCP (134KB) Patients (123KB) IFU (2.58MB) |
|
|
None |
| 06/23/2020 | 06/23/2020 | University of Alabama at Birmingham Fungal Reference Lab | FRL SARS CoV-2 Test (99KB) | MolecularВ Real-time RT-PCR | H |
HCP (104KB) |
|
|
None |
| 06/23/2020 | 09/21/2020 | HealthQuest Esoterics | HealthQuest Esoterics TaqPath SARS-CoV-2 Assay (103KB) | MolecularВ Real-time RT-PCR | H | HCP (104KB) Patients (94KB) EUA Summary (306KB) |
|
|
None |
| 06/23/2020 | 06/23/2020 | Babson Diagnostics, Inc. | Babson Diagnostics aC19G1 (322KB) | Serology IgG, CLIA | H |
HCP (146KB) |
|
|
None |
| 06/24/2020 | 06/24/2020 | University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory | MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay (288KB) | MolecularВ Real-time RT-PCR | H | HCP (104KB) Patients (94KB) EUA Summary (145KB) |
|
|
None |
| 06/25/2020 | 06/25/2020 | PlexBio Co., Ltd | IntelliPlex SARS-CoV-2 Detection Kit (168KB) | MolecularВ RT-PCR | H | HCP (137KB) Patients (126KB) IFU (10.10MB) |
|
|
None |
| 06/25/2020 | 06/25/2020 | PreciGenome LLC | FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) (135KB) | MolecularВ RT-digital droplet PCR | H | HCP (105KB) Patients (91KB) IFU (1.65MB) |
|
|
None |
| 06/25/2020 | 06/25/2020 | Diagnostic Solutions Laboratory, LLC | DSL COVID-19 Assay (285KB) | MolecularВ Real-time RT-PCR | H | HCP (104KB) Patients (93KB) EUA Summary (203KB) |
|
|
None |
| 06/26/2020 | 06/26/2020 | Inform Diagnostics, Inc. | Inform Diagnostics SARS-CoV-2 RT-PCR Assay (288KB) | MolecularВ Real-time RT-PCR | H | HCP (104KB) Patients (94KB) EUA Summary (191KB) |
|
|
None |
| 06/29/2020 | 06/29/2020 | LifeHope Labs | LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel (282KB) | MolecularВ Real-time RT-PCR | H | HCP (104KB) Patients (94KB) EUA Summary (128KB) |
|
|
None |
| 06/26/2020 | 06/26/2020 | Beckman Coulter, Inc. | Access SARS-CoV-2 IgG (342KB) | SerologyВ IgG, CLIA | H, M | HCP (80KB) Recipients (129KB) IFU (315KB) |
|
|
None |
| 06/29/2020 | 09/24/2020 | Acupath Laboratories, Inc. | Acupath COVID-19 Real-Time (RT-PCR) Assay (284KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (94KB) EUA Summary (137KB) |
|
|
None |
| 06/30/2020 | 06/30/2020 | The Kroger Co. | Kroger Health COVID-19 Test Home Collection Kit (311KB) | Molecular Home Collection Kit | В | IFU (69KB) EUA Summary (147KB) |
|
|
None |
| 06/30/2020 | 06/30/2020 | TNS Co., Ltd (Bio TNS) | COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit (321KB) | Molecular RT-PCR | H | HCP (143KB) Patients (135KB) IFU (1.20MB) |
|
|
None |
| 06/30/2020 | 09/21/2020 | Psomagen, Inc. | Psoma COVID-19 RT Test (284KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (94KB) EUA Summary (225KB) |
|
|
None |
| 06/30/2020 | 06/30/2020 | InBios International, Inc. | SCoV-2 Detect IgM ELISA (115KB) | SerologyВ IgM, ELISA | H | HCP (166KB) Recipients (158KB) IFU (419KB) |
|
|
None |
| 07/01/2020 | 07/01/2020 | CENTOGENE US, LLC | CentoFast-SARS-CoV-2 RT-PCR Assay (106KB) | MolecularВ Real-time RT-PCR | H | HCP (137KB) Patients (125KB) EUA Summary (178KB) |
|
|
None |
| 07/02/2020 | 09/21/2020 | Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (143KB) | Molecular Real-time RT-PCR, Multi-analyte | H | HCP (153KB) Patients (134KB) IFU (1.46MB) |
|
|
None |
| 07/02/2020 | 07/23/2020 | Becton, Dickinson and Company (BD) | BD Veritor System for Rapid Detection of SARS-CoV-2В (139KB) | AntigenВ Chromatographic Digital Immunoassay, Instrument Read | H, M, W | HCPВ (147KB) PatientsВ (162KB) IFUВ (1.92MB) |
|
None | |
| 07/06/2020 | 07/06/2020 | Laboratorio Clinico Toledo | Laboratorio Clinico Toledo SARS-CoV-2 Assay (285KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (93KB) EUA Summary (125KB) |
|
|
None |
| 07/06/2020 | 09/23/2020 | Assure Tech. (Hangzhou Co., Ltd) | Assure COVID-19 IgG/IgM Rapid Test Device (356KB) | Serology IgM and IgG, Lateral Flow | H, M, W | HCP (147KB) Recipients (133KB) IFU (1.84MB) |
|
|
Ecotest COVID-19 IgG/IgM Rapid Test DeviceВ Fastep COVID-19 IgG/IgM Rapid Test Device |
| 07/07/2020 | 07/07/2020 | Enzo Life Sciences, Inc. | AMPIPROBE SARS-CoV-2 Test System (134KB) | MolecularВ Real-time RT-PCR | H | HCP (139KB) Patients (127KB) IFU (1.23MB) |
|
|
None |
| 07/07/2020 | 07/07/2020 | Access Bio, Inc. | CareStart COVID-19 MDx RT-PCR (132KB) | MolecularВ Real-time RT-PCR | H | HCP (137KB) Patients (148KB) IFU (1.02MB) |
|
|
None |
| 07/07/2020 | 07/07/2020 | Gene By Gene | Gene By Gene SARS-CoV-2 Detection Test (103KB) | MolecularВ Real-time RT-PCR | H | HCP (103KB) Patients (93KB) EUA Summary (212KB) |
|
|
None |
| 07/08/2020 | 10/23/2020 | Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard | CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (319KB) (Reissued October 23, 2020) | MolecularВ Real-time RT-PCR | H | HCP (157KB) Patients (143KB) EUA Summary (509KB) IFU (Home Collect) (615KB) |
|
None | |
| 07/08/2020 | 07/08/2020 | Diazyme Laboratories, Inc. | Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit (137KB) | SerologyВ IgG, CLIA | H, M | HCP (80KB) Recipients (126KB) IFU (201KB) |
|
|
None |
| 07/09/2020 | 07/09/2020 | UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin | SARS-CoV-2 RNA DETECTR Assay (289KB) | Molecular RT-LAMP | H | HCP (105KB) Patients (94KB) EUA Summary (83KB) |
|
|
None |
| 07/09/2020 | 07/09/2020 | BioSewoom, Inc. | Real-Q 2019-nCoV Detection Kit (323KB) | MolecularВ Real-time RT-PCR | H | HCP (137KB) Patients (125KB) IFU (513KB) |
|
|
None |
| 07/10/2020 | 07/10/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab Rapid Test (139KB) | Serology, Total Antibody, Lateral Flow | H, M | HCP (157KB) Recipients (136KB) IFU (137KB) |
|
|
None |
| 07/10/2020 | 07/10/2020 | Boston Medical Center | BMC-CReM COVID-19 Test (103KB) | MolecularВ Real-time RT-PCR | H | HCP (104KB) Patients (92KB) EUA Summary (141KB) |
|
|
None |
| 07/13/2020 | 07/13/2020 | Compass Laboratory Services, LLC | Compass Laboratory Services SARS-CoV2 Assay (120KB) | Molecular Real-time RT-PCR, Home Collection | H | HCP (90KB) Patients (104KB) EUA Summary (94KB) |
|
|
None |
| 07/13/2020 | 08/08/2020 | Trax Management Services Inc. | PhoenixDx SARS-CoV-2 Multiplex (139KB) | MolecularВ Real-time RT-PCR | H | HCP (254KB) Patients (187KB) IFU (644KB) |
|
None | |
| 07/13/2020 | 09/21/2020 | KogeneBiotech Co., Ltd. | PowerChek 2019-nCoV Real-time PCR Kit (149KB) | MolecularВ Real-time RT-PCR | H | HCP (150KB) Patients (138KB) IFU (620KB) |
|
|
None |
| 07/13/2020 | 07/13/2020 | Salofa Oy | Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette (129KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (96KB) Recipients (147KB) IFU (398KB) |
|
|
None |
| 07/15/2020 | 08/21/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics HA SARS-CoV-2 Assay (132KB) (Reissued August 21, 2020) | Molecular TMA, chemiluminescent, Home Collection | H | HCP (154KB) Patients (142KB) EUA Summary (79KB) IFU (Home Collect) (810KB) |
|
|
None |
| 07/15/2020 | 08/21/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics RC SARS-CoV-2 Assay (133KB) (Reissued August 21, 2020) | MolecularВ Real-time RT-PCR, Home Collection | H | HCP (155KB) Patients (142KB) EUA Summary (67KB) IFU (Home Collect) (811KB) |
|
|
None |
| 07/15/2020 | 08/21/2020 | Quest Diagnostics Infectious Disease, Inc. | Quest Diagnostics PF SARS-CoV-2 Assay (132KB) (Reissued August 21, 2020) | Molecular Real-time RT-PCR, Home Collection | H | HCP (149KB) Patients (142KB) EUA Summary (54KB) IFU (Home Collect) (810KB) |
|
|
None |
| 07/16/2020 | 09/21/2020 | Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test (104LB) | MolecularВ Real-time RT-PCR | H | HCP (104KB) Patients (93KB) EUA Summary (253KB) |
|
|
None |
| 07/16/2020 | 07/16/2020 | Luminex Corporation | xMAP SARS-CoV-2 Multi-Antigen IgG Assay (139KB) | Serology IgG, FMIA | H | HCP (113KB) Recipients (124KB) IFU (366KB) |
|
|
None |
| 07/17/2020 | 09/25/2020 | Access Genetics, LLC | OraRisk COVID-19 RT-PCR (293KB) (Reissued September 25, 2020) | MolecularВ Real-time RT-PCR | H | HCP (145KB) Patients (132KB) EUA Summary (476KB) |
|
|
None |
| 07/17/2020 | 07/17/2020 | Megna Health, Inc. | Rapid COVID-19 IgM/IgG Combo Test Kit (127KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (91KB) Recipients (104KB) IFU (201KB) |
|
|
None |
| 07/21/2020 | 07/21/2020 | DiaCarta, Inc. | QuantiVirus SARS-CoV-2 Multiplex Test Kit (134KB) | MolecularВ Real-time RT-PCR | H | HCP (140KB) Patients (127KB) IFU (642KB) |
|
|
None |
| 07/23/2020 | 10/22/2020 | Helix OpCo LLC | Helix COVID-19 Test (348KB) (Reissued October 22, 2020) | MolecularВ Real-time RT-PCR, Home Collection, Screening | H | HCP (141KB) Patients (131KB) EUA Summary (468KB) IFU (Home Collect) (495KB) |
|
|
None |
| 07/24/2020 | 07/24/2020 | Jiangsu CoWin Biotech Co., Ltd. | Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) (146KB) | MolecularВ Real-time RT-PCR | H | HCP (148KB) Patients (135KB) IFU (1.39MB) |
|
|
None |
| 07/24/2020 | 10/30/2020 | Xiamen Biotime Biotechnology Co., Ltd. | BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test (129KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (155KB) Recipients (141KB) IFU (289KB) |
|
None | |
| 07/24/2020 | 10/31/2020 | Access Bio, Inc. | CareStart COVID-19 IgM/IgG (153KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (170KB) Recipients (156KB) IFU (535KB) |
|
AQGene COVID-19 MDx RT-PCR Rapid Response Liberty COVID-19 IgG/IgM |
|
| 05/18/2020 | 11/02/2020 | Color Genomics, Inc. | Color SARS-Cov-2 RT-LAMP Diagnostic Assay (reissued November 2, 2020) (111KB) | Molecular RT, LAMP, Home Collection | H | HCP (148KB) Patients (135KB) EUA Summary (281KB) |
|
None | |
| 07/27/2020 | 07/27/2020 | Sandia National Laboratories | SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay (298KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (95KB) EUA Summary (222KB) |
|
|
None |
| 07/27/2020 | 09/21/2020 | Eli Lilly and Company | Lilly SARS-CoV-2 Assay (288KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (95KB) EUA Summary (328KB) |
|
None | |
| 07/30/2020 | 07/30/2020 | Clinical Reference Laboratory, Inc. | CRL Rapid Response (110KB) | Molecular, Real-time RT-PCR, Home Collection, Saliva | H | HCP (103KB) Patients (91KB) EUA Summary (176KB) IFU (Home Collect) (586KB) |
|
|
None |
| 07/31/2020 | 07/31/2020 | Siemens Healthcare Diagnostics Inc. | Atellica IM SARS-CoV-2 IgG (COV2G) (244KB) | IgG, Semi-quantitative | H, M | HCP (149KB) Recipients (133KB) IFU (1.09MB) |
|
|
None |
| 07/31/2020 | 07/31/2020 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur SARS-CoV-2 IgG (COV2G) (156KB) | IgG, Semi-quantitative | H, M | HCP (149KB) Recipients (134KB) IFU (1.11MB) |
|
|
None |
| 07/31/2020 | 07/31/2020 | Xiamen Zeesan Biotech Co., Ltd. | SARS-CoV-2 Test Kit (Real-time PCR) (134KB) | MolecularВ Real-time RT-PCR | H | HCP (142KB) Patients (129KB) IFU (370KB) |
|
|
None |
| 07/31/2020 | 07/31/2020 | University of California San Diego Health | UCSD RC SARS-CoV-2 Assay (107KB) | Molecular Real-time RT-PCR, Pooling | H | HCP (92KB) Patients (92KB) EUA Summary (77KB) |
|
|
None |
| 08/03/2020 | 10/20/2020 | Wren Laboratories LLC | Wren Laboratories COVID-19 PCR Test (121KB) (Reissued October 20, 2020) | MolecularВ Real-time RT-PCR, Home Collection, Saliva | H | HCP (158KB) Patients (145KB) EUA Summary (300KB) IFU (Home Collect) (918KB) |
|
|
None |
| 08/03/2020 | 09/21/2020 | Ethos Laboratories | Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay (124KB) | Molecular RT-PCR and MALDI-TOF Mass Spec., Home Collection | H | HCP (115KB) Patients (97KB) EUA Summary (637KB) IFU (Home Collect) (469KB) |
|
|
None |
| 08/03/2020 | 08/03/2020 | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | Cleveland Clinic SARS-CoV-2 Assay (116KB) | MolecularВ Real-time RT-PCR | H | HCP (116KB) Patients (105KB) EUA Summary (205KB) |
|
|
None |
| 08/03/2020 | 08/03/2020 | Poplar Healthcare | Poplar SARS-CoV-2 TMA Pooling assay (118KB) | Molecular TMA, chemiluminescent, Pooling | H | HCP (152KB) Patients (139KB) EUA Summary (138KB) |
|
|
None |
| 08/03/2020 | 08/03/2020 | ISPM Labs, LLC dba Capstone Healthcare | Genus SARS-CoV-2 Assay (292KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (92KB) EUA Summary (360KB) |
|
|
None |
| 08/05/2020 | 08/05/2020 | Vela Operations Singapore Pte Ltd | ViroKey SARS-CoV-2 RT-PCR Test (144KB) | MolecularВ Real-time RT-PCR | H | HCP (163KB) Patients (163KB) IFU (4.13MB) |
|
|
None |
| 08/05/2020 | 08/05/2020 | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab ELISA (128KB) | Serology Total Antibody, ELISA | H | HCP (166KB) Recipients (152KB) IFU (237KB) |
|
|
None |
| 08/06/2020 | 08/06/2020 | Helix OpCo LLC (dba Helix) | Helix COVID-19 NGS Test (115KB) | Molecular Sequencing | H | HCP (116KB) Patients (99KB) EUA Summary (177KB) |
|
|
None |
| 08/06/2020 | 08/06/2020 | bioMГ©rieux SA | VIDAS SARS-CoV-2 IgG (183KB) | Serology IgG, ELFA | H, MВ | HCP (157KB) Recipients (144KB) IFU (366KB) |
|
|
None |
| 08/06/2020 | 08/06/2020 | bioMГ©rieux SA | VIDAS SARS-CoV-2 IgM (182KB) | Serology IgM, ELFA | H, M | HCP (151KB) Recipients (144KB) IFU (364KB) |
|
|
None |
| 08/07/2020 | 08/07/2020 | George Washington University Public Health Laboratory | GWU SARS-CoV-2 RT-PCR Test (115KB) | MolecularВ Real-time RT-PCR | H | HCP (116KB) Patients (105KB) EUA Summary (134KB) |
|
|
None |
| 08/10/2020 | 08/10/2020 | Solaris Diagnostics | Solaris Multiplex SARS-CoV-2 Assay (115KB) | MolecularВ Real-time RT-PCR | H | HCP (121KB) Patients (105KB) EUA Summary (148KB) |
|
|
None |
| 08/10/2020 | 08/10/2020 | Alpha Genomix Laboratories | Alpha Genomix TaqPath SARS-CoV-2 Combo Assay (115KB) | MolecularВ Real-time RT-PCR | H | HCP (116KB) Patients (100KB) EUA Summary (178KB) |
|
|
None |
| 08/11/2020 | 08/11/2020 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR (145KB) | MolecularВ RT, non-isothermal nucleic acid amplification qSTAR | H | HCP (150KB) Patient (137KB) IFU (1.57MB) |
|
|
None |
| 08/11/2020 | 08/11/2020 | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test (147KB) | MolecularВ Real-time RT-PCR | H | HCP (150KB) Patient (138KB) IFU (2.63MB) |
|
|
None |
| 08/13/2020 | 08/13/2020 | Pro-Lab Diagnostics | Pro-AmpRT SARS-CoV-2 Test (131KB) | MolecularВ RT, Isothermal amplification | H | HCP (115KB) Patient (104KB) EUA Summary (179KB) |
|
|
None |
| 08/15/2020 | 10/15/2020 | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | SalivaDirectВ (320KB) (reissued August 28, 2020) | MolecularВ Real-time RT-PCR, Saliva | H | HCPВ (145KB) PatientsВ (133KB) EUA SummaryВ (210KB) |
|
None | |
| 08/17/2020 | 08/17/2020 | ZhuHai Sinochips Bioscience Co., Ltd. | COVID-19 Nucleic Acid RT-PCR Test Kit (169KB) | MolecularВ Real-time RT-PCR | HВ | HCP (158KB) Patients (142KB) IFU (913KB) |
|
|
None |
| 08/17/2020 | 08/17/2020 | BioCheck, Inc. | BioCheck SARS-CoV-2 IgG and IgM Combo Test (166KB) | Serology IgM and IgG, CLIA | H, M | HCP (156KB) Recipients (142KB) IFU (701KB) |
|
|
None |
| 08/17/2020 | 08/17/2020 | Diazyme Laboratories, Inc. | Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit (148KB) | Serology IgM, CLIA | H, M | HCP (157KB) Recipients (143KB) IFU (213KB) |
|
|
None |
| 08/18/2020 | 08/18/2020 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 Ag Test (137KB) | AntigenВ Microfluidic Immunofluorescence Assay, Instrument Read | H, M, W | HCP (142KB) Patients (131KB) IFU (11.92MB) |
|
|
None |
| 08/21/2020 | 08/21/2020 | Texas Department of State Health Services, Laboratory Services Section | Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay (107KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (94KB) EUA Summary (194KB) |
|
|
None |
| 08/21/2020 | 08/21/2020 | DxTerity Diagnostics, Inc. | DxTerity SARS-CoV-2 RT-PCR Test (98KB) | MolecularВ Real-time RT-PCR, Saliva | H | HCP (140KB) Patients (125KB) EUA Summary (135KB) |
|
|
None |
| 08/21/2020 | 08/21/2020 | Guardant Health, Inc. | Guardant-19 (104KB) | MolecularВ Sequencing | H | HCP (105KB) Patients (94KB) EUA Summary (337KB) |
|
|
None |
| 08/25/2020 | 08/25/2020 | QDx Pathology Services | QDX SARS-CoV-2 Assay (299KB) | Molecular Real-time RT-PCR, Home Collection | H | HCP (103KB) Patients (92KB) EUA Summary (332KB) IFU (Home Collect) (872KB) |
|
|
None |
| 08/25/2020 | 11/05/2020 | Fluidigm Corporation | Advanta Dx SARS-CoV-2 RT-PCR Assay (330KB) | MolecularВ Real-time RT-PCR, Saliva | H | HCP (142KB) Patients (128KB) IFU (1.08MB) |
|
|
None |
| 08/25/2020 | 08/25/2020 | Biocan Diagnostics Inc. | Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (343KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (160KB) Recipients (138KB) IFU (338KB) |
|
|
None |
| 08/26/2020 | 08/26/2020 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card (325KB) | AntigenВ Lateral Flow, Visual Read | H, M, W | HCP (145KB) Patients (134KB) IFU (498KB) |
|
|
None |
| 08/26/2020 | 10/02/2020 | Cuur DiagnosticsВ | Cuur Diagnostics SARS-CoV-2 Molecular Assay (110KB) (Reissued October 2, 2020) | MolecularВ Real-time RT-PCR | H | HCP (158KB) Patients (146KB) EUA Summary (106KB) |
|
|
None |
| 08/28/2020 | 08/28/2020 | DxTerity Diagnostics, Inc. | DxTerity SARS-CoV-2 RT PCR CE Test (299KB) | Molecular Real-time RT-PCR, Home Collection, Screening, Saliva | H | HCP (143KB) Patients (130KB) EUA Summary (1.19MB) IFU (Home Collect) (2.5MB) |
|
|
None |
| 08/28/2020 | 09/21/2020 | Patients Choice Laboratories, LLC | PCL SARS-CoV-2 Real-Time RT-PCR Assay (280KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (94KB) EUA Summary (166KB) |
|
|
None |
| 08/31/2020 | 08/31/2020 | BayCare Laboratories, LLC | BayCare SARS-CoV-2 RT PCR Assay (289KB) | MolecularВ Real-time RT-PCR, Pooling | H | HCP (86KB) Patients (92KB) EUA Summary (444KB) |
|
|
None |
| 08/31/2020 | 08/31/2020 | Mammoth Biosciences, Inc. | SARS-CoV-2 DETECTR Reagent Kit (313KB) | MolecularВ RT-LAMP, CRISPR | H | HCP (141KB) Patients (129KB) IFU (461KB) |
|
|
None |
| 08/31/2020 | 08/31/2020 | MiraDx | MiraDx SARS-CoV-2 RT-PCR assay (294KB) | MolecularВ Real-time RT-PCR | H | HCP (105KB) Patients (95KB) EUA Summary (438KB) |
|
|
None |
| 08/31/2020 | 10/22/2020 | T2 Biosystems, Inc. | T2SARS-CoV-2 Panel (314KB) | MolecularВ RT, amplification, T2 Magnetic resonance | H, M | HCP (137KB) Patients (124KB) IFU (1.26MB) |
|
|
None |
| 08/31/2020 | 08/31/2020 | University of Arizona Genetics Core for Clinical Services | COVID-19 ELISA pan-Ig Antibody Test (339KB) | Serology Total Antibody, ELISA | H | HCP (149KB) Recipients (132KB) EUA Summary (302KB) |
|
|
None |
| 08/31/2020 | 08/31/2020 | TBG Biotechnology Corp. | TBG SARS-CoV-2 IgG / IgM Rapid Test Kit (332KB) | Serology IgM and IgG, Lateral Flow | H, M | HCP (146KB) Recipients (133KB) IFU (548KB) |
|
|
None |
| 08/31/2020 | 09/15/2020 | Color Genomics, Inc. | Color COVID-19 Test Self-Swab Collection Kit (142KB) (Re-issued September 15, 2020) | Home Collection Kit | В | EUA Summary (142KB) IFU (105KB) |
|
|
None |
| 09/01/2020 | 09/01/2020 | OPTOLANE Technologies, Inc. | Kaira 2019-nCoV Detection Kit (141KB) | MolecularВ Real-time RT-PCR | H | HCP (153KB) Patients (141KB) IFU (3.56MB) |
|
|
None |
| 09/01/2020 | 10/06/2020 | Detectachem Inc. | MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit (147KB) (Reissued October 2, 2020) | MolecularВ RT, LAMP | H | HCP (155KB) Patients (143KB) IFU (829KB) |
|
|
None |
| 09/02/2020 | 10/23/2020 | Bioeksen R&D Technologies Ltd. | Bio-Speedy Direct RT-qPCR SARS-CoV-2 (126KB) | MolecularВ Real-time RT-PCR | H | HCP (145KB) Patients (133KB) IFU (999KB) |
|
|
None |
| 09/03/2020 | 10/28/2020 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B (155KB) | Molecular Real-time RT-PCR, Multi-analyte | H, M | HCP (172KB) Patients (155KB) IFU (1.75MB) |
|
|
None |
| 09/03/2020 | 09/03/2020 | Sugentech, Inc. | SGTi-flex COVID-19 IgG (138KB) | Serology IgG, Lateral Flow | H, MВ | HCP (152KB) Recipients (138KB) IFU (492KB) |
|
|
None |
| 09/04/2020 | 09/04/2020 | BillionToOne, Inc. | qSanger-COVID-19 Assay (138KB) | Molecular Sequencing | H | HCP (151KB) Patients (138KB) IFU (1.56MB) |
|
|
None |
| 09/08/2020 | 09/08/2020 | Verily Life Sciences | Verily COVID-19 RT-PCR Test (134KB) | Molecular Real-time RT-PCR, Pooling | H | HCP (151KB) Patients (138KB) EUA Summary (1.14MB) |
|
|
None |
| 03/31/2020 | 06/04/2020 | Yale New Haven Hospital, Clinical Virology Laboratory |
SARS-CoV-2 PCR test (72KB) В |
Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (121KB) |
None | ||
| 04/02/2020 | 04/02/2020 | Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia | SARS-CoV-2 RT-PCR test (121KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (333 KB) |
|
None | |
| 04/02/2020 | 04/02/2020 | Diagnostic Molecular Laboratory - Northwestern Medicine | SARS-Cov-2 Assay (152KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (272KB) |
|
None | |
| 04/03/2020 | 04/03/2020 | Massachusetts General Hospital | MGH COVID-19 qPCR assay (68KB) | Molecular, U | H | HCP (134KB) Patients (122KB)EUA Summary (122KB) |
|
None | |
| 04/06/2020 | 10/15/2020 | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay (119KB) (Reissued October 15, 2020)В | Molecular Real-time RT-PCR, Home Collection, Pooling | H | HCP (147KB) Patients (135KB) EUA SummaryВ (313KB) |
|
None | |
| 04/08/2020 | 04/08/2020 | Stanford Health Care Clinical Virology Laboratory | Stanford SARS-CoV-2 assay (79KB) | Molecular, U | H | HCP (134KB) Patients (122KB)EUA Summary (180KB) |
|
None | |
| 04/10/2020 | 04/10/2020 | Specialty Diagnostic (SDI) Laboratories | SDI SARS-CoV-2 AssayLetter Granting Inclusion (68KB) | Molecular, U | H | HCP (134KB) Patients (122KB)EUA Summary (160KB) |
|
None | |
| 04/10/2020 | 04/10/2020 | Orig3n, Inc. | Orig3n 2019 Novel Coronavirus (COVID-19) Test (68KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (140KB) |
|
None | |
| 04/10/2020 | 09/21/2020 | University of North Carolina Medical Center | UNC Health SARS-CoV-2 real-time RT-PCR test (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB)EUA Summary (691KB) |
|
None | |
| 04/13/2020 | 09/21/2020 | Pathology/Laboratory Medicine Lab of Baptist Hospital Miami | COVID-19 RT-PCR Test (121KB) | Molecular, U | H | HCP (134KB) Patients (122KB)EUA Summary (405KB) |
|
None | |
| 04/13/2020 | 04/13/2020 | Integrity Laboratories | SARS-CoV-2 Assay (121KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (409KB) |
|
None | |
| 04/14/2020 | 04/14/2020 | Exact Sciences Laboratories | SARS-CoV-2 Test (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (513KB) |
|
None | |
| 04/14/2020 | 09/21/2020 | Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital | Childrens-Altona-SARS-CoV-2 Assay (145KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (246KB) |
|
None | |
| 04/15/2020 | 09/21/2020 | CirrusDx Laboratories | CirrusDx SARS-CoV-2 Assay (164KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (502KB) |
|
None | |
| 04/15/2020 | 09/21/2020 | Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | CDI Enhanced COVID-19 Test (218KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (456KB) |
|
None | |
| 04/20/2020 | 07/29/2020 | Mayo Clinic Laboratories, Rochester, MN | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (186KB) |
None | |||
| 04/22/2020 | 09/22/2020 | Diatherix Eurofins Laboratory | SARS-CoV-2 PCR Test (68KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (133KB) |
|
None | |
| 04/23/2020 | 04/23/2020 | Southwest Regional PCR Laboratory LLC. dba MicroGen DX | COVID-19 Key (121KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (419KB) |
|
None | |
| 04/24/2020 | 04/24/2020 | AIT Laboratories | SARS-CoV-2 Assay (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (423KB) |
|
None | |
| 04/24/2020 | 04/24/2020 | Ultimate Dx Laboratory | UDX SARS-CoV-2 Molecular Assay (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (554KB) |
|
None | |
| 04/27/2020 | 04/27/2020 | Nationwide Children’s Hospital | SARS-CoV-2 Assay (67KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (185KB) |
|
None | |
| 04/30/2020 | 06/04/2020 | Altru Diagnostics, Inc. | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (143KB) |
None | |||
| 04/28/2020 | 04/28/2020 | Biocerna | SARS-CoV-2 Test (218KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (307KB) |
|
None | |
| 05/03/2020 | 07/22/2020 | UTMG Pathology Laboratory | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (143KB) |
None | |||
| 05/07/2020 | 05/07/2020 | Biocollections Worldwide, Inc. | Biocollections Worldwide SARS-Co-V-2 Assay (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (365KB) |
|
None | |
| 05/12/2020 | 05/12/2020 | Columbia University Laboratory of Personalized Genomic Medicine | TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST (214KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (296KB) |
None | ||
| 05/13/2020 | 05/13/2020 | One Health Laboratories, LLC | SARS-CoV-2 Real-Time RT-PCR-Test (222KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (394KB |
|
None | |
| 05/13/2020 | 05/13/2020 | Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | SARS-CoV-2-Assay (223KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (424KB) |
|
None | |
| 05/22/2020 | 05/22/2020 | Express Gene LLC (dba Molecular Diagnostics Laboratory) | Express Gene 2019-nCoV RT-PCR Diagnostic Panel (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (143KB) |
|
None | |
| 05/22/2020 | 05/22/2020 | Avera Institute for Human Genetics | Avera Institute for Human Genetics SARS-CoV-2 Assay (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (143KB) |
|
None | |
| 06/02/2020 | 06/02/2020 | CSI Laboratories | CSI SARS-CoV-2 RT PCR Test (223KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (385KB) |
|
None | |
| 06/01/2020 | 06/01/2020 | Aspirus Reference Laboratory | Aspirus SARS-CoV-2 rRT Assay (222KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (368KB) |
|
None | |
| 06/04/2020 | 06/04/2020 | Nebraska Medicine Clinical Laboratory | NEcov19 RT-PCR Assay (120KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (195KB) |
|
None | |
| 06/09/2020 | 06/09/2020 | Warrior Diagnostics, Inc. | Warrior Diagnostics SARS-CoV-2 Assay (67KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (90KB) |
|
None | |
| 06/12/2020 | 06/12/2020 | Cormeum Laboratory Services | Cormeum SARS-CoV-2 Assay (67KB) | Molecular, U | H | HCP (134KB) Patients (122KB) EUA Summary (117KB) |
|
None |
1 Settings for use include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. В§263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. В§263a, that meet requirements to perform moderate complexity tests.В
- W - Patient care settings operating under a CLIA Certificate of Waiver.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
3 Abbreviations: CLIA = chemiluminescence immunoassay; ELISA = enzyme-linked immunosorbent assay; ECLIA = electrochemiluminescence immunoassay; FMIA = fluorescent microsphere Immunoassay; CMIA = chemiluminescent microparticle immunoassay; RT-PCR = reverse transcriptase polymerase chain reaction; RT = reverse transcriptase; LAMP = loop-mediated isothermal amplification; MALDI-TOF = Matrix Assisted Laser Desorption/Ionization – Time of Flight; TMA = Transcription Mediated Amplification; qSTAR = Selective Temperature Amplification Reaction; CRISPR = clustered regularly interspaced short palindromic repeats
4В U = On March 31, 2020, FDA issued an umbrella EUA for High Complexity Molecular-Based Laboratory Developed Tests. The EUA letter of authorization is here. Tests that are authorized under this EUA are designated by "U" in the table.
Personal Protective Equipment and Related Devices
For information on the applicable HHS Secretary determination and declaration supporting a particular EUA in the table below, as well as a link to any applicable PREP Act declaration, please use the expansion buttons on the left hand side of the table.
For additional information, please see Recent Final Medical Device Guidance Documents and Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers.
Please also see the Non-NIOSH Approved Respirator FAQВ for additional information.
On August 20, 2020, the umbrella EUA for certain protective barrier enclosures was revoked. (See also the FDA's letter to healthcare providers and statement.)
В
Ventilators and Other Medical Devices
In continuing response to the COVID-19 pandemic, on March 24, 2020, and based on the February 4, 2020 HHS EUA determination, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak. The EUAs FDA subsequently authorized based on this determination and declaration are listed in the table below this blue box.
- Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (March 24, 2020)
The HHS Secretary issued a Declaration pursuant to section 319F-3 of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID-19.
- Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
1В The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The В multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH. The multiBic replacement fluid is regulated as a drug by CDER.
Drug and Biological Products
On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. On the basis of this determination, the Secretary then declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.
- Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (February 4, 2020)
- Emergency Use Authorization Declaration (March 27, 2020)
On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met.  Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19.
- Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate (PDF, 125 KB)
- EspaГ±olВ (PDF-159KB);В з®ЂдЅ“дёж–‡В (PDF-264KB);В н•њкµм–ґВ (PDF-440KB);В TagalogВ (PDF-118KB);В ViệtВ (PDF-245KB)
| Date of First EUA Issuance | Most Recent Letter of Authorization (PDF) | Authorized Use 1 | Fact Sheets and Manufacturer Instructions/ Package Insert (PDF) | Federal Register Notice for EUA | EUA Determination and Declaration (Effective Date) |
|---|---|---|---|---|---|
| 11/09/2020 | BamlanivimabВ (326KB) | For the treatment of mild-to-moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. |
Healthcare ProvidersВ (528KB) Patients, Parents, and CaregiversВ (127KB)
Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab (250KB) |
|
Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) |
| 08/23/2020 | COVID-19 convalescent plasmaВ (277KB) | For the treatment of hospitalized patients with Coronavirus Disease 2019 (COVID-19) |
Healthcare Providers (259KB)
Patients and Parents/ Caregivers (202KB)
Summary Information 9/23/2020В (380KB) Decision Memorandum (505KB) Emergency Use Authorization requestВ (510KB) |
|
Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) |
| 08/13/2020 | REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit (92KB) | To be used as a replacement solution only in adult patients treated with continuous renal replacement therapy (CRRT), and for whom regional citrate anticoagulation is appropriate, in a critical care setting | Healthcare Providers (108KB) Patients and Caregivers (52KB) REGIOCIT package insert for EUA (140KB) |
|
Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) |
| 05/08/2020 | Fresenius Kabi Propoven 2%В (209KB) | To maintain sedation via continuous infusion in patients older than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting 2В | Healthcare ProvidersВ (288KB) Patients and Parent/CaregiversВ (39KB) Propoven 2% Wall Chart (2.4MB) |
|
|
| 05/01/2020 | Remdesivir for Certain Hospitalized COVID-19 Patients (423KB) (Reissued October 22, 2020) |
For emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.  This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. For additional information, also see: FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness |
Healthcare Providers (375KB) Patients and Parent/ Caregivers (94KB)
Frequently Asked Questions on the EUA for Veklury (remdesivir) for Certain Hospitalized PatientsВ (189KB) (Updated October 22, 2020
|
Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) | |
| 04/30/2020 | Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions (171KB) 3 [also listed under Medical Device EUAs] |
To provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic. |
Healthcare Providers (135KB) Patients (125KB) Instructions for Use, Bloodline/ Tubing (83KB) Instructions for Use, UltraFlux (147KB) Instructions for Use, multiFiltratePRO (15.07MB) Summary of Product Characteristics (SmPC) (308KB) Instructions for Use, MultiPlus (110KB) |
Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) |
1 The virus that causes COVID-19 has led to an increased number of patients requiring critical care, such as В with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved В drugs used for their treatment, such as propofol for sedation of mechanically ventilated patients. В
2 In the circumstances of this public health emergency, it would not be feasible to require healthcare providers to seek to limit Fresenius Propoven 2% Emulsion only to be used for patients with suspected or confirmed COVID-19; therefore, this authorization does not limit use to such patients.
3 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The multiBic replacement fluid is regulated as a drug by CDER. The multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH.
Other Current EUAs
The tables below provide information on current EUAs:
- Anthrax EUAs
- Ebola Virus EUA Information
- Enterovirus D68 (EV-D68) EUA Information
- Freeze Dried Plasma Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Nerve Agent EUA Information
- Zika Virus EUA Information
Information about EUAs that are no longer in effect is available on our EUA archive page.
The 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) together replace the need for the doxycycline mass dispensing EUA (issued on July 21, 2011). Therefore, the doxycycline emergency dispensing order and EUI should be used by stakeholders for anthrax preparedness and response instead of the mass dispensing EUA.
The July 21, 2011, doxycycline mass dispensing EUA, and the October 14, 2011, National Postal Model anthrax EUA will be terminated by FDA, and notice of such termination will be published in the Federal Register. ForВ additional information, seeВ Emergency Use Authorization--Archived Information.
Ebola preparedness and response updates from FDAВ (all agency activities)
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
Ebola Diagnostic Tests with De Novo, 510(k) or PMA
- OraQuickEbola Rapid Antigen Test - On October 10, 2019, FDA allowed marketing (PDF,В 255 KB) of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for Ebola virus disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. Also see the FDA news release: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens
The OraQuick Ebola Test was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this marketing authorization, the FDA is establishing criteria, called special controls, that determine the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to identify Ebola virus antigens. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and DeclarationВ (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
EZ1 Real-time RT-PCR AssayВ |
August 5, 2014 (initial issuance) October 10, 2014 (reissuance) В |
Authorization (PDF,В 61 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В | |
|
CDC Ebola Virus NP Real-time RT-PCR AssayВ |
October 10, 2014В (initial issuance)В March 2, 2015 (reissuance) October 8, 2019 (amended) В |
Authorization (PDF,В 282 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
|
|
CDC Ebola Virus VP40 Real-time RT-PCR AssayВ |
October 10, 2014В (initial issuance)В March 2, 2015 (reissuance) October 8, 2019 (amended) В |
Authorization (PDF,В 285 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
|
|
FilmArray NGDS BT-E AssayВ |
October 25, 2014В (initialВ issuance)В March 2, 2015 (reissuance) В |
Authorization (PDF,В 326 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
|
|
FilmArray Biothreat-E testВ |
October 25, 2014В November 12, 2019 (amended)В |
Authorization (PDF,В 73 KB)В В В В В В В |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В | |
|
RealStar Ebolavirus RT-PCR Kit 1.0В |
November 10, 2014В (initial issuance) November 26, 2014 (reissuance) В В |
Authorization (PDF,В В 263 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
|
|
LightMix Ebola Zaire rRT-PCR TestВ |
December 23, 2014 |
Authorization (PDF,В В 2.2 MB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
|
|
Xpert Ebola Assay |
March 23, 2015 |
Authorization (PDF,В В 240 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
|
|
Idylla Ebola Virus Triage TestВ (Biocartis NV) |
May 26, 2016 |
Authorization В (PDF,В В 321 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
|
|
DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.) |
November 9, 2018 April 2, 2019 (amended) |
Authorization В (PDF,В В 103 KB) Letter Granting EUA Amendment(s) (PDF, 87 KB) |
|
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola VirusВ (August 4, 2014) |
В |
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and DeclarationВ (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) |
May 12, 2015 |
Authorization (PDF,В 229 KB) |
|
Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015) |
В |
Also see FDA News Release: FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product (July 10, 2018)
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and DeclarationВ (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
Pathogen-Reduced Leukocyte-Depleted Freeze Dried Plasma (Centre de Transfusion Sanguine des ArmГ©es) В |
July 9, 2018 (initial issuance) May 8, 2020 (amendment) |
Authorization (PDF,В 203 KB) Letter granting EUA amendments (PDF, 60 KB) |
|
DeterminationВ by DoD (June 7, 2018) Declaration Regarding Emergency Use of Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat (July 9, 2018) |
В |
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheet and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable)В |
|---|---|---|---|---|---|---|
|
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay |
April 22, 2013 (initial issuance) В March 27, 2018 (reissuance) |
AuthorizationВ (PDF,В 301 KB), re-issued March 27, 2018 В |
|
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.) |
|
|
Quidel Lyra Influenza A Subtype H7N9 Assay |
February 14, 2014 |
Authorization (PDF, 57 KB) |
|
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.) |
|
|
A/H7N9 Influenza Rapid Test |
April 25, 2014 |
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.) |
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
CDC Novel Coronavirus 2012 Real-time RT-PCR Assay |
June 5, 2013 (initial issuance) June 10, 2014 (reissuance) В В |
Authorization (PDF, 2.2 MB) |
|
В |
||
|
RealStar MERS-CoV RT-PCR Kit U.S. |
July 17, 2015 February 12, 2016 (reissuance) В В |
Authorization (PDF, 238 KB) |
|
В |
On July 9, 2018, FDA approved (PDF, В 49 KB) the 2 mg Atropine Auto-Injector manufactured by Rafa Laboratories, Ltd., for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides in adults and pediatric patients weighing over 90 lbs [41 kg] (generally over 10 years of age). For more information about the approved 2 mg Rafa Atropine Auto-Injector, see the product label (PDF, 482 KB). The EUA detailed in the table below is still in effect.
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
Atropine Auto-Injector (Rafa Laboratories Ltd.) |
April 11, 2017 (initial issuance) May 23, 2017 (amended) January 24, 2018 (amended) March 6, 2018 (amended) May 15, 2018 (amended) |
Letter of Authorization (PDF,В 514 KB) Letter granting EUA amendment(s) (PDF,В 28 KB) 2nd letter granting EUA amendment(s) (PDF, 33 KB) 3rd letter granting EUA amendment(s) (PDF, 85 KB) 4th letter granting EUA amendment(s) (PDF, 42 KB) |
|
Determination and Declaration Regarding Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning (April 11, 2017) |
Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures (April 11, 2017) |
Zika virus response updates from FDA
Zika virus diagnostic development information
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
Draft EUA review templates for Zika are available by email request to: CDRH-ZIKA-Templates@fda.hhs.gov
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.
Zika Diagnostic Tests with De Novo, 510(k), or PMA
- ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing (PDF, 175 KB) of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s EUA authority. Also see the FDA news release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
- ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
- LIAISON XL Zika Capture IgM Assay II – On October 28, 2019, FDA cleared the LIAISON XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
- DPP Zika IgM Assay System – On June 3, 2020, FDA cleared a similar DPP Zika IgM System for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
| Medical Product | Date of EUA Issuance | Letters | Federal Register Notice for EUA |
Fact Sheets and Manufacturer Instructions/Package Insert |
EUA Determination and DeclarationВ (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
|
CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay |
February 26, 2016 (initial issuance) June 29, 2016В (amended) November 15, 2016 (amended) December 6, 2016 (amended) May 3, 2017 (amended) July 31, 2017 (amended) April 16, 2018 (amended) September 26, 2018 (amended) |
Letter granting EUA amendment(s) (PDF, 155 KB) Letter granting EUA amendment(s) (PDF, 123 KB) Letter granting EUA amendment(s) (PDF,В 110В KB) Letter granting EUA amendment(s) (PDF,В 113 KB) Letter granting EUA amendment(s) (PDF,В 131 KB) Letter granting EUA amendment(s) (PDF,В 131 KB) |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) |
March 17, 2016 (initial issuance) September 21, 2016 (amended) January 12, 2017 (amended) February 28, 2017 (amended) April 6, 2017В (amended) |
Authorization (PDF,В 82 KB) Letter granting EUA amendment(s) (PDF, 223 KB) Letter granting EUA amendment(s) (PDF, 223 KB) Letter granting EUA amendment(s) (PDF, 223 KB) Letter granting EUA amendment(s) (PDF,В 126 KB) |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.) |
April 28, 2016 (initial issuance) October 7, 2016 (reissuance) April 11, 2017 (amended) |
AuthorizationВ (PDF,В 339 KB) Letter granting EUA amendment(s) (PDF,В 126 KB) |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH) |
May 13, 2016 (initial issuance) October 31, 2016 (amended) MarchВ 6, 2017 (amended) |
Authorization (PDF,В 342 KB) Letter Granting EUA Amendment(s) (PDF, 130 KB) Letter Granting EUA Amendment(s) (PDF, 130 KB) |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Aptima Zika Virus assay (Hologic, Inc.) |
June 17, 2016 (initial issuance) September 7, 2016 (amended) April 12, 2017 (amended) March 8, 2018 (amended) В |
Authorization (PDF,В 305 KB) Letter granting EUA amendment(s) (PDF, 126 KB) Letter granting EUA amendment(s) (PDF, 124В KB) Letter granting EUA amendment(s) (PDF, 130 KB) В |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Zika Virus Real-time RT-PCR Test (Viracor Eurofins) |
July 19, 2016 (initial issuance) February 28, 2017 (amended) |
Authorization (PDF,В 334 KB) Letter granting EUA amendment(s) (PDF, 124 KB) |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.) |
July 29, 2016 (initial issuance) December 19, 2016 (amended) |
Authorization (PDF,В 78 KB) Letter granting EUA amendment(s) (PDF, 124 KB) |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.) |
September 23, 2016 |
Authorization (PDF,В В 355 KB) |
|
В Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Zika VirusВ Detection by RT-PCR Test (ARUP Laboratories) |
September 28, 2016 |
Authorization (PDF,В В 98 KB) |
|
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Abbott RealTime ZIKA (Abbott Molecular Inc.) |
November 21, 2016 (initial issuance) January 6, 2017 (amended) |
Authorization (PDF,В 84 KB) Letter granting EUA amendment(s) (PDF, 150 KB) |
|
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics) |
December 9, 2016 |
Authorization (PDF,В 312 KB) |
|
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.) |
March 20, 2017 |
Authorization (PDF,В 313 KB) |
|
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
В |
|
|
TaqPath Zika Virus Kit (Thermo Fisher Scientific) |
August 2, 2017 |
Authorization (PDF,В 292 KB) |
|
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) В |
В |
|
|
CII-ArboViroPlex rRT-PCR Assay (Columbia University) |
August 11, 2017 |
Authorization (PDF,В 377 KB) |
|
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Related Links
- Coronavirus Disease 2019 (COVID-19)
- Summary of Process for EUA Issuance
- Current Emergency Use Authorizations for Medical Devices
- How to Submit a Pre-EUA for In vitro Diagnostics (IVDs)В to FDA (for test manufacturers)
- Information for Laboratories Implementing IVD Tests Under EUA
- Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019 (June 2, 2020)
- Emergency Use Authorization--Archived Information
- Emergency Dispensing Orders
- 21st Century Cures Act: MCM-Related Cures Provisions
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
- Public Readiness and Emergency Preparedness (PREP) Act
- HHS Public Health Emergency EUA Authorization Declarations
- Ebola Preparedness and Response Updates from FDA
- Zika Virus Response Updates from FDA
- Historical Information about Device Emergency Use Authorizations