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  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization

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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 needed during public health emergencies. 

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) 

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).  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. 

PREP Act - COVID-19 Related Information

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.

Printable PDF (288 KB)

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.

 

Coronavirus Disease 2019 (COVID-19) EUA Information

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. 

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-2 and CLIA and University Laboratory Testing FAQ (CMS)

 

Date EUA First Issued Most Recent Authorization or Revision Entity Diagnostic (Most Recent Letter of Authorization) (PDF) Product Attributes 3, 4 Authorized Setting(s) 1 Authorization Labeling 2 (PDF) Amendments and Other Documents (PDF) Federal Register Notice for EUA Other Brand Name(s)
12/16/2020 12/16/2020 Hologic, Inc. Aptima SARS-CoV-2/Flu assay (135KB) Molecular Real-time TMA, chemiluminescent, Multi-analyte H HCP (163KB)
Patients (147KB)
IFU (289KB)
  • None currently
  • None currently
 None
12/16/2020 12/16/2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card Home Test (130KB) Antigen Lateral Flow, Visual Read, Prescription Home Testing   HCP (148KB)
IFU (1.65MB)
IFU (Home Test) (3.10MB)
  • None currently
  • None currently
 None
12/15/2020 12/15/2020 ACON Laboratories, Inc. ACON SARS-CoV-2 IgG/IgM Rapid Test (151KB) Serology IgM and IgG, Lateral Flow H, M HCP (161KB)
Recipients (148KB)
IFU (790KB)
  • None currently
  • None currently
 None
12/11/2020 12/11/2020 ResearchDx, Inc., DBA Pacific Diagnostics PacificDx Covid-19 (117KB) Molecular TMA, chemiluminescent, Home Collection H HCP (158KB)
Patients (146KB)
EUA Summary (133KB)
  • None currently
  • None currently
 None
12/15/2020 12/15/2020 RCA Laboratory Services LLC dba GENETWORx GENETWORx Covid-19 Nasal Swab Test (111KB) Molecular Real-time RT-PCR, Home Collection H HCP (161KB)
Patients (149KB)
EUA Summary (532KB)
IFU (Home Collect) (990KB)
  • None currently
  • None currently 
 None
12/16/2020 12/16/2020 Ellume Limited Ellume COVID-19 Home Test (107KB) Antigen Lateral Flow, Fluorescence, Instrument Read, Over the Counter   HCP (159KB)
IFU (875KB)
IFU (Home Test) (2.07MB)
  • None currently
  • None currently
 None
12/09/2020 12/09/2020 Laboratory Corporation of America (LabCorp) Pixel by LabCorp COVID-19 Test Home Collection Kit (109KB) Molecular Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening H HCP (152KB)
Individuals (141KB)
EUA Summary (565KB)
IFU (Home Collect) (2.29MB)
  • None currently
  • None currently
 None
12/07/2020 12/07/2020 Luminostics, Inc. Clip COVID Rapid Antigen Test (150KB) Antigen Lateral flow immunoluminescent assay, instrument read H, M, W HCP (92KB)
Patients (105KB)
IFU (3.44MB)
  • None currently
  • None currently
 None
12/04/2020 12/04/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics RC COVID-19+Flu RT-PCR (109KB) Molecular Real-time RT-PCR, Multi-analyte, Home Collection H HCP (209KB)
Patients (142KB)
EUA Summary (113KB)
IFU (Home Collection) (667KB)
  • None currently
  • None currently
 None
11/23/2020 11/23/2020 Innovita (Tangshan) Biological Technology Co., Ltd. Innovita 2019-nCoV Ab Test (Colloidal Gold) (153KB) Serology IgM and IgG, Lateral Flow H, M HCP (167KB)
Recipients (153KB)
IFU (491KB)
  • None currently
  • None currently
 None
11/25/2020 11/25/2020 Roche Diagnostics, Inc. Elecsys Anti-SARS-CoV-2 S (151KB) Serology Total Antibody, ECLIA, Semi-quantitative H, M HCP (158KB)
Recipients (143KB)
IFU (308KB)
  • None currently 
  • None currently
 None
11/27/2020 11/27/2020 Cepheid Xpert Omni SARS-CoV-2 (159KB) Molecular Real-time RT-PCR H, M HCP (151KB)
Patients (137KB)
IFU (14.12MB)
  • None currently
  • None currently
 None
11/24/2020 11/24/2020 Kantaro Biosciences, LLC COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit (138KB) Serology IgG, ELISA, Semi-quantitative H HCP (171KB)
Recipients (163KB)
IFU (1.39MB)
  • None currently
  • None currently
 None
11/23/2020 11/23/2020 Gravity Diagnostics, LLC Gravity Diagnostics SARS-CoV-2 RT-PCR Assay (125KB) Molecular Real-time RT-PCR, Home Collection, Screening, Saliva H HCP (161KB)
Patients (148KB)
EUA Summary (273KB)
  • None currently
  • None currently
 None
11/23/2020 11/23/2020 RapidRona, Inc. RapidRona Self-Collection Kit (134KB) Home Collection Kit N/A EUA Summary (141KB)
IFU (Collection) (1.87MB)
  • None currently
  • None currently
 None
11/18/2020 11/18/2020 Lucira Health, Inc. Lucira COVID-19 All-In-One Test Kit (334KB) Prescription Home Testing W HCP (145KB)
IFU (1.31MB)
IFU (Home Test) (415KB) 
  • None currently
  • None currently
 None
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 currently
  • None currently
 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 currently 
  • None currently
 None
10/28/2020 10/28/2020 DNA Genotek Inc. ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices (351KB) Saliva Collection Device N/A EUA Summary (312KB)
IFU (670KB)
  • None currently
  • None currently
 None
10/26/2020 11/30/2020 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 (1.60MB)
  • None currently
 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 currently 
  • None currently
 None
10/20/2020 12/04/2020 binx health, Inc. binx health At-Home Nasal Swab COVID-19 Sample Collection Kit (304KB) (Reissued December 4, 2020) Home Collection Kit N/A EUA Summary (305KB)
IFU (1.61MB)
  • None currently
  • None currently
 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 currently
  • None currently
 None
10/14/2020 10/28/2020 DNA Genotek Inc. OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices (309KB) (Reissued October 28, 2020)  Saliva Collection Device N/A EUA Summary (596KB)
IFU (358KB)
  • None currently
  • None currently
 None
10/14/2020 10/14/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR Complete (145KB) Molecular RT, qSTAR amplification H HCP (153KB)
Patients (130KB)
IFU (1.75MB)
  • None currently 
  • None currently 
 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 currently
  • None currently
 None
10/08/2020 10/13/2020 Access Bio, Inc. CareStart COVID-19 Antigen test (327KB) Antigen Lateral Flow, Visual Read H, M, W HCP (167KB)
Patients (154KB)
IFU (1.44MB)
  • None currently
  • None currently
 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 currently 
  • None currently 
 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 currently 
  • None currently 
 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 currently 
  • None currently
 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 currently
  • None currently
 None
10/06/2020 10/06/2020 ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 IgG Test System (127KB) Serology IgG, ELISA H, M HCP (159KB)
Recipients (150KB)
IFU (364KB)
  • None currently
  • None currently
 None
10/06/2020 10/08/2020 University of California, Los Angeles (UCLA) UCLA SwabSeq COVID-19 Diagnostic Platform (297KB)  Molecular RT-PCR and Sequencing H HCP (163KB)
Patients (150KB)
EUA Summary (160KB)
  • None currently
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 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 currently 
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 None
10/01/2020 10/01/2020 Tempus Labs, Inc. iC SARS-CoV2 Test (292KB) Molecular Real-time RT-PCR H HCP (138KB)
Patients (125KB)
EUA Summary (583KB)
  • None currently
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 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, M  HCP (162KB)
Recipients (149KB)
IFU (215KB)
  • None currently
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 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 currently
  • None currently
 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 currently
 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 currently
  • None currently
 None
09/24/2020 10/01/2020 Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV 09/24/2020 (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-Care (2.20MB)
  • None currently
  • None currently
 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 currently
  • None currently
 None
09/23/2020 11/10/2020 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 currently
 INDICAID COVID-19 IgM/IgG Rapid Test
09/22/2020 09/22/2020 Quadrant Biosciences Inc. Clarifi COVID-19 Test Kit 09/22/2020 (146KB) Molecular Real-time RT-PCR, Saliva H HCP (152KB)
Patients (138KB)
IFU (325KB)
  • None currently
  • None currently
 None
09/22/2020 09/22/2020 Vela Operations Singapore Pte. Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0 09/22/2020 (143KB) Molecular Real-time RT-PCR H HCP (156KB)
Patients (144KB0
IFU (3.3MB)
  • None currently
  • None currently
 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 currently 
  • None currently
 None
09/18/2020 09/18/2020 GK Pharmaceuticals Contract Manufacturing Operations GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT (320KB) Molecular Real-time RT-PCR H HCP (154KB)
Patients (145KB)
IFU (707KB)
  • None currently 
  • None currently
 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 currently 
  • None currently
 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 currently
 None
09/14/2020 12/10/2020 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 (4.52MB)		 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 currently
 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 currently
 None
09/09/2020 10/31/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 RT-PCR Kit (137KB) Molecular 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) Molecular Real-time RT-PCR H HCP (136KB)
Patients (124KB)
IFU (548KB)
  • None currently
 None
02/04/2020 12/01/2020 CDC CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (143KB) (Reiussed December 1, 2020) Molecular Real-time RT-PCR, Pooling H HCP (164KB)
Patients (151KB)
IFU (2.56MB)		 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) Molecular Real-time RT-PCR H HCP (140KB)
Patients (117KB)
IFU (314KB)		 None
03/12/2020 11/18/2020 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2 (149KB) (Reissued October 15, 2020) Molecular Real-time RT-PCR, Pooling H, M HCP (145KB)
Patients (133KB)
IFU (1.39MB)		 None
03/13/2020 11/20/2020 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit (386KB) (Reissued October 9, 2020) Molecular Real-time RT-PCR, Home Collection H HCP (180KB)
Patients (168KB)
IFU (3.57MB)		 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 (119KB) (Reissued December 9, 2020) Molecular Real-time RT-PCR, Home Collection, Pooling, Screening H HCP (149KB)
Patients (136KB)
EUA Summary (480KB)
IFU - LabCorp Home Collect (230KB)		 None
03/17/2020 04/08/2020 Quidel Corporation Lyra SARS-CoV-2 Assay (294KB) Molecular Real-time RT-PCR H HCP (133KB)
Patients (121KB)
IFU (479KB)		 None
03/17/2020 11/13/2020 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 (148KB)
Patients (139KB)
IFU (352KB)
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) Molecular 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) Molecular 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) Molecular 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) Molecular Real-time RT-PCR H, M, W HCP (151KB)
Patients (137KB)
IFU - Laboratories (391KB)
IFU - Point of Care (1.10MB)		 None
03/23/2020 12/04/2020 BioFire Defense, LLC BioFire COVID-19 Test (307 KB) (Reissued December 4, 2020) Molecular RT, Nested multiplex PCR, Pooling H, M HCP (144KB)
Patients (131KB)
IFU (1.11MB)		 None
03/23/2020 08/24/2020 Mesa Biotech Inc. Accula SARS-Cov-2 Test (322 KB) Molecular 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) Molecular 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) Molecular 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) Molecular 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) Molecular RT-PCR H HCP (136KB)
Patients (123KB)
IFU (1.02MB)
  • None currently.
 None
03/30/2020 04/23/2020 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay (127KB) Molecular 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 currently
 None
04/01/2020 04/01/2020 Ipsum Diagnostics, LLC COV-19 IDx assay (288KB) Molecular Real-time RT-PCR H HCP (133KB)
Patients (121KB)
EUA Summary (130KB)
  • None currently.
 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) Molecular 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) Molecular 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) Molecular RT-PCR, CoPrimer technology H HCP (135KB)
Patients (123KB)
IFU (476KB)
  • None currently.
 None
04/06/2020 04/28/2020 Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit (320KB) Molecular Real-time RT-digital PCR H HCP (135KB)
Patients (123KB)
IFU (227KB)
  • None currently.
 None
04/07/2020 10/02/2020 InBios International, Inc. Smart Detect SARS-CoV-2 rRT-PCR Kit (128KB) Molecular 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) Molecular 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) Molecular Real-time RT-PCR H HCP (156KB)
Patients (143KB)
IFU (2.03MB)
  • None currently.
 None
04/10/2020 07/18/2020 Atila BioSystems, Inc. iAMP COVID-19 Detection Kit (124KB) Molecular 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) Molecular 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 currently.
 None
04/16/2020 04/16/2020 GenoSensor, LLC GS COVID-19 RT-PCR KIT (317KB) Molecular Real-time RT-PCR H HCP (133KB)
Patients (121KB)
IFU (408KB)
  • None currently.
 None
04/16/2020 06/11/2020 KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay (280KB) Molecular 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) Molecular Real-time RT-PCR H HCP (249KB)
Patients (190KB)
IFU (860KB)
  • None currently.
 None
04/18/2020 04/18/2020 OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit (320KB) Molecular Real-time RT-PCR H HCP (137KB)
Patients (125KB)
IFU (494KB)
  • None currently.
 None
04/20/2020 08/08/2020 Trax Management Services Inc. PhoenixDx 2019-CoV (134KB) Molecular 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) Molecular 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) Molecular Real-time RT-PCR H HCP (138KB)
Patients (126KB)
IFU (566KB)
  • None currently.
 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 Kit (129KB) Molecular Real-time RT-PCR H HCP (153KB)
Patients (141KB)
IFU (1.05MB)		 None
04/26/2020 12/01/2020 Abbott Laboratories Inc. SARS-CoV-2 IgG assay (367KB) Serology IgG, CMIA H, M HCP (177KB)
Recipients (142KB)
IFU-ARCHITECT (3.10MB)
IFU-Alinityi (2.96MB)		 None
04/29/2020 09/22/2020 LabGenomics Co., Ltd. LabGun COVID-19 RT-PCR Kit (134KB) Molecular Real-time RT-PCR H HCP (109KB)
Patients (98KB)
IFU (1.35MB)
  • None currently.
 None
04/29/2020 12/03/2020 Rheonix, Inc. Rheonix COVID-19 MDx Assay (330KB) (Reissued December 3, 2020) Molecular RT-PCR, Saliva H HCP (143KB)
Patients (131KB)
IFU (692KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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 currently
 None
05/01/2020 12/09/2020 Bio-Rad Laboratories, Inc. Bio-Rad SARS-CoV-2 ddPCR Test (320KB) (Reissued September 18, 2020) Molecular RT-droplet PCR H HCP (141KB)
Patients (129KB)
IFU (2.67MB)		 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 currently
 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 currently
 None
05/04/2020 05/04/2020 Sansure BioTech Inc.  Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (360KB) Molecular Real-time RT-PCR H HCP (212KB)
Patients (171KB)
IFU (988KB)
  • None currently
 None
05/05/2020 07/09/2020 Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) FTD SARS-CoV-2 (300KB) Molecular 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) Molecular 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) Molecular RT-LAMP, CRISPR H HCP (250KB)
Patients (190KB)
IFU (538KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
05/06/2020 11/06/2020 BioMérieux SA SARS-COV-2 R-GENE (422KB) Molecular 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 Kit (396KB) Molecular Real-time RT-PCR H HCP (289KB)
Patients (245KB)
IFU (641KB)		 None
04/10/2020 11/30/2020 Infinity BiologiX LLC Infinity BiologiX TaqPath SARS-CoV-2 Assay (317KB)
(reissued November 13, 2020)		 Molecular Real-time RT-PCR, Home Collection, Saliva H HCP (150KB)
Patients (132KB)
IFU (591KB)
IFU (Home Collect) (591KB)
EUA Summary (631KB)
  • Vault Health COVID-19 Test
  • USGC Saliva Test Kit, hims/hers Saliva Test Kit
  • BioIQ COVID-19 Saliva Test
  • Concentric by Ginkgo
  • 1health.io Zero Contact
  • Base10 Saliva Test Kit
  • Purlab. Saliva Test Kit
  • Reliant Saliva Test Kit
  • E7 Health Saliva Test Kit
  • miinehealth Saliva Test Kit
  • Maverick Saliva Test Kit
  • SDTL Saliva Test Kit
  • AZOVA At-Home COVID-19 Test Collection Kit
05/08/2020 07/17/2020 Quidel Corporation Sofia 2 SARS Antigen FIA (138KB) Antigen Lateral Flow, Fluorescence, Instrument Read H, M, W HCP (152KB)
Patients (136KB)
IFU (2.39MB)		 None
05/08/2020 05/08/2020 Gnomegen LLC Gnomegen COVID-19-RT-qPCR Detection Kit (314KB) Molecular Real-time RT-PCR H HCP (135KB)
Patients (123KB)
IFU (1.36MB)
  • None currently
 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 currently

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 11/21/2020 Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit (393KB) Molecular Real-time RT-PCR H HCP (154KB)
Patients (142KB)
IFU (280KB)		 None
05/14/2020 10/05/2020 Hologic, Inc. Aptima SARS-CoV-2 assay (153KB) (Reissued October 5, 2020) Molecular 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) Molecular Real-time RT-PCR H HCP (139KB)
Patients (98KB)
IFU (1.09MB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
05/18/2020 05/18/2020 Quidel Corporation Lyra Direct SARS-CoV-2 Assay (396KB) Molecular Real-time RT-PCR H HCP (250KB)
Patients (190KB)
IFU (596KB)
  • None currently
 None
05/21/2020 09/21/2020 BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit (415KB) Molecular Real-time RT-PCR H HCP (252KB)
Patients (190KB)
IFU (1.88MB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
05/21/2020 05/21/2020 SolGent Co., Ltd. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (393KB) Molecular Real-time RT-PCR H HCP (250KB)
Patients (209KB)
IFU (2.06MB)
  • None currently
 None
05/21/2020 05/21/2020 Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit (395KB) Molecular RT-LAMP, CRISPR H HCP (254KB)
Patients (192KB)
IFU (1.02MB)
  • None currently
 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) Molecular 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 currently
 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 currently
 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 currently
 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 currently
 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 currently
 None
06/04/2020 12/15/2020 Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test (125KB) (Reissued December 15, 2020) Molecular Real-time RT-PCR, Home Collection, Saliva H HCP (159KB)
Patients (146KB)
EUA Summary (376KB)
IFU (Home Collect) (1.44MB)
IFU (Clinic) (296KB)		 Wheeler Labs COVID-19 RT-qPCR Test
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) Molecular Real-time RT-PCR H HCP (157KB)
Patients (124KB)
IFU (300KB)
  • None currently
 None
06/08/2020 11/04/2020 Euroimmun US Inc. EURORealTime SARS-CoV-2 (138KB) Molecular Real-time RT-PCR H HCP (196KB)
Patients (KB)
IFU (290KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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) Molecular Real-time RT-PCR H HCP (134KB)
Patients (121KB)
IFU (2.46MB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
06/10/2020 08/20/2020 Cue Health Inc. Cue COVID-19 Test (144KB) Molecular 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) Molecular Real-time RT-PCR H HCP (149KB)
Patients (137KB)
IFU (420KB)
  • None currently
 None
06/10/2020 06/10/2020 Tide Laboratories, LLC DTPM COVID-19 RT-PCR Test (136KB) Molecular Real-time RT-PCR H HCP (146KB)
Patients (134KB)
EUA Summary (170KB)
  • None currently
 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 currently
 None
06/12/2020 06/12/2020 RTA Laboratories Biological Products Pharmaceutical and Machinery Industry Diagnovital SARS-CoV-2 Real-Time PCR Kit (149KB) Molecular Real-time RT-PCR H HCP (149KB)
Patients (135KB)
IFU (446KB)
  • None currently
 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 currently
 None
06/15/2020 12/07/2020 Applied BioCode, Inc. BioCode SARS-CoV-2 Assay (151KB) (Reissued December 7, 2020) Molecular RT-PCR, Pooling H HCP (156KB)
Patients (143KB)
IFU (573KB)		 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 currently
 None
06/17/2020 06/17/2020 Omnipathology Solutions Medical Corporation Omni COVID-19 Assay by RT-PCR (115KB) Molecular Real-time RT-PCR H HCP (115KB)
Patients (104KB)
EUA Summary (167KB)
  • None currently
 None
06/17/2020 06/17/2020 The Ohio State University Wexner Medical Center OSUWMC COVID-19 RT-PCR test (114KB) Molecular Real-time RT-PCR H HCP (116KB)
Patients (104KB)
EUA Summary (158KB)
  • None currently
 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) Molecular Real-time RT-PCR H HCP (155KB)
Patients (149KB)
IFU (1.16MB)
  • None currently
 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 12/02/2020 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 (176KB)
Recipients (157KB)
IFU (1.14MB)		 QUICKKIT Novel Coronavirus (2019-nCov) IgM/IgG Antibody Combo Test Kit
06/23/2020 06/23/2020 Gencurix, Inc. GenePro SARS-CoV-2 Test (134KB) Molecular Real-time RT-PCR H HCP (134KB)
Patients (123KB)
IFU (2.58MB)
  • None currently
 None
06/23/2020 06/23/2020 University of Alabama at Birmingham Fungal Reference Lab FRL SARS CoV-2 Test (99KB) Molecular Real-time RT-PCR H

HCP (104KB)
Patients (93KB)
EUA Summary (189KB)
  • None currently
 None
06/23/2020 09/21/2020 HealthQuest Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay (103KB) Molecular Real-time RT-PCR H HCP (104KB)
Patients (94KB)
EUA Summary (306KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
06/23/2020 06/23/2020 Babson Diagnostics, Inc. Babson Diagnostics aC19G1 (322KB) Serology IgG, CLIA H

HCP (146KB)
Recipients (128KB)
EUA Summary (102KB)
  • None currently
 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) Molecular Real-time RT-PCR H HCP (104KB)
Patients (94KB)
EUA Summary (145KB)
  • None currently
 None
06/25/2020 06/25/2020 PlexBio Co., Ltd IntelliPlex SARS-CoV-2 Detection Kit (168KB) Molecular RT-PCR H HCP (137KB)
Patients (126KB)
IFU (10.10MB)
  • None currently
 None
06/25/2020 06/25/2020 PreciGenome LLC FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) (135KB) Molecular RT-digital droplet PCR H HCP (105KB)
Patients (91KB)
IFU (1.65MB)
  • None currently
 None
06/25/2020 06/25/2020 Diagnostic Solutions Laboratory, LLC DSL COVID-19 Assay (285KB) Molecular Real-time RT-PCR H HCP (104KB)
Patients (93KB)
EUA Summary (203KB)
  • None currently
 None
06/26/2020 06/26/2020 Inform Diagnostics, Inc. Inform Diagnostics SARS-CoV-2 RT-PCR Assay (288KB) Molecular Real-time RT-PCR H HCP (104KB)
Patients (94KB)
EUA Summary (191KB)
  • None currently
 None
06/29/2020 06/29/2020 LifeHope Labs LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel (282KB) Molecular Real-time RT-PCR H HCP (104KB)
Patients (94KB)
EUA Summary (128KB)
  • None currently
 None
06/26/2020 06/26/2020 Beckman Coulter, Inc. Access SARS-CoV-2 IgG (342KB) Serology IgG, CLIA H, M HCP (80KB)
Recipients (129KB)
IFU (315KB)
  • None currently
 None
06/29/2020 09/24/2020 Acupath Laboratories, Inc. Acupath COVID-19 Real-Time (RT-PCR) Assay (284KB) Molecular Real-time RT-PCR H HCP (105KB)
Patients (94KB)
EUA Summary (137KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
06/30/2020 06/30/2020 The Kroger Co. Kroger Health COVID-19 Test Home Collection Kit (311KB) Molecular Home Collection Kit   IFU (69KB)
EUA Summary (147KB)
  • None currently
 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 currently
 None
06/30/2020 09/21/2020 Psomagen, Inc. Psoma COVID-19 RT Test (284KB) Molecular Real-time RT-PCR H HCP (105KB)
Patients (94KB)
EUA Summary (225KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
06/30/2020 06/30/2020 InBios International, Inc. SCoV-2 Detect IgM ELISA (115KB) Serology IgM, ELISA H HCP (166KB)
Recipients (158KB)
IFU (419KB)
  • None currently
 None
07/01/2020 07/01/2020 CENTOGENE US, LLC CentoFast-SARS-CoV-2 RT-PCR Assay (106KB) Molecular Real-time RT-PCR H HCP (137KB)
Patients (125KB)
EUA Summary (178KB)
  • None currently
 None
07/02/2020 11/20/2020 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 (1.77MB)		 None
07/02/2020 07/23/2020 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2 (139KB) Antigen Chromatographic Digital Immunoassay, Instrument Read H, M, W HCP (147KB)
Patients (162KB)
IFU (1.92MB)		 None
07/06/2020 07/06/2020 Laboratorio Clinico Toledo Laboratorio Clinico Toledo SARS-CoV-2 Assay (285KB) Molecular Real-time RT-PCR H HCP (105KB)
Patients (93KB)
EUA Summary (125KB)
  • None currently
 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)
  • None currently

Ecotest COVID-19 IgG/IgM Rapid Test Device 

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) Molecular Real-time RT-PCR H HCP (139KB)
Patients (127KB)
IFU (1.23MB)
  • None currently
 None
07/07/2020 07/07/2020 Access Bio, Inc. CareStart COVID-19 MDx RT-PCR (132KB) Molecular Real-time RT-PCR H HCP (137KB)
Patients (148KB)
IFU (1.02MB)
  • None currently
 None
07/07/2020 07/07/2020 Gene By Gene Gene By Gene SARS-CoV-2 Detection Test (103KB) Molecular Real-time RT-PCR H HCP (103KB)
Patients (93KB)
EUA Summary (212KB)
  • None currently
 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) Molecular 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) Serology IgG, CLIA H, M HCP (80KB)
Recipients (126KB)
IFU (201KB)
  • None currently
 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 currently
 None
07/09/2020 07/09/2020 BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit (323KB) Molecular Real-time RT-PCR H HCP (137KB)
Patients (125KB)
IFU (513KB)
  • None currently
 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 currently
 None
07/10/2020 07/10/2020 Boston Medical Center BMC-CReM COVID-19 Test (103KB) Molecular Real-time RT-PCR H HCP (104KB)
Patients (92KB)
EUA Summary (141KB)
  • None currently
 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 currently
 None
07/13/2020 11/20/2020 Trax Management Services Inc. PhoenixDx SARS-CoV-2 Multiplex (139KB) Molecular Real-time RT-PCR H HCP (254KB)
Patients (187KB)
IFU (505KB)		 None
07/13/2020 09/21/2020 KogeneBiotech Co., Ltd. PowerChek 2019-nCoV Real-time PCR Kit (149KB) Molecular Real-time RT-PCR H HCP (150KB)
Patients (138KB)
IFU (620KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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 currently
 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 currently
 None
07/15/2020 11/27/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics RC SARS-CoV-2 Assay (139KB) (Reissued November 27, 2020) Molecular Real-time RT-PCR, Home Collection, Pooling H HCP (160KB)
Patients (147KB)
EUA Summary (84KB)
IFU (Home Collect) (812KB)
  • None currently
 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 currently
 None
07/16/2020 09/21/2020 Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR Test (104LB) Molecular 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 currently
 None
07/17/2020 09/25/2020 Access Genetics, LLC OraRisk COVID-19 RT-PCR (293KB) (Reissued September 25, 2020) Molecular Real-time RT-PCR H HCP (145KB)
Patients (132KB)
EUA Summary (476KB)
  • None currently
 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 currently
 None
07/21/2020 07/21/2020 DiaCarta, Inc. QuantiVirus SARS-CoV-2 Multiplex Test Kit (134KB) Molecular Real-time RT-PCR H HCP (140KB)
Patients (127KB)
IFU (642KB)
  • None currently
 None
07/23/2020 10/22/2020 Helix OpCo LLC Helix COVID-19 Test (348KB) (Reissued October 22, 2020) Molecular Real-time RT-PCR, Home Collection, Screening H HCP (141KB)
Patients (131KB)
EUA Summary (468KB)
IFU (Home Collect) (495KB)
  • None currently
 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) Molecular Real-time RT-PCR H HCP (148KB)
Patients (135KB)
IFU (1.39MB)
  • None currently
 None
07/24/2020 11/06/2020 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 (302KB)		 Telepoint SARS-CoV-2 IgG/IgM Rapid Qualitative Test
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) Molecular Real-time RT-PCR H HCP (105KB)
Patients (95KB)
EUA Summary (222KB)
  • None currently
 None
07/27/2020 09/21/2020 Eli Lilly and Company Lilly SARS-CoV-2 Assay (288KB) Molecular 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 currently
 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 currently
 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 currently
 None
07/31/2020 11/10/2020 Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit (Real-time PCR) (134KB) Molecular Real-time RT-PCR H HCP (149KB)
Patients (136KB)
IFU (387KB)		 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 currently
 None
08/03/2020 10/20/2020 Wren Laboratories LLC Wren Laboratories COVID-19 PCR Test (121KB) (Reissued October 20, 2020) Molecular Real-time RT-PCR, Home Collection, Saliva H HCP (158KB)
Patients (145KB)
EUA Summary (300KB)
IFU (Home Collect) (918KB)
  • None currently
 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) Molecular Real-time RT-PCR H HCP (116KB)
Patients (105KB)
EUA Summary (205KB)
  • None currently
 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 currently
 None
08/03/2020 08/03/2020 ISPM Labs, LLC dba Capstone Healthcare Genus SARS-CoV-2 Assay (292KB) Molecular Real-time RT-PCR H HCP (105KB)
Patients (92KB)
EUA Summary (360KB)
  • None currently
 None
08/05/2020 08/05/2020 Vela Operations Singapore Pte Ltd ViroKey SARS-CoV-2 RT-PCR Test (144KB) Molecular Real-time RT-PCR H HCP (163KB)
Patients (163KB)
IFU (4.13MB)
  • None currently
 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 currently
 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 currently 
 None
08/06/2020 08/06/2020 bioMérieux SA VIDAS SARS-CoV-2 IgG (183KB) Serology IgG, ELFA H, M  HCP (157KB)
Recipients (144KB)
IFU (366KB)
  • None currently
 None
08/06/2020 08/06/2020 bioMérieux SA VIDAS SARS-CoV-2 IgM (182KB) Serology IgM, ELFA H, M HCP (151KB)
Recipients (144KB)
IFU (364KB)
  • None currently
 None
08/07/2020 08/07/2020 George Washington University Public Health Laboratory GWU SARS-CoV-2 RT-PCR Test (115KB) Molecular Real-time RT-PCR H HCP (116KB)
Patients (105KB)
EUA Summary (134KB)
  • None currently
 None
08/10/2020 08/10/2020 Solaris Diagnostics Solaris Multiplex SARS-CoV-2 Assay (115KB) Molecular Real-time RT-PCR H HCP (121KB)
Patients (105KB)
EUA Summary (148KB)
  • None currently
 None
08/10/2020 08/10/2020 Alpha Genomix Laboratories Alpha Genomix TaqPath SARS-CoV-2 Combo Assay (115KB) Molecular Real-time RT-PCR H HCP (116KB)
Patients (100KB)
EUA Summary (178KB)
  • None currently
 None
08/11/2020 08/11/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR (145KB) Molecular RT, non-isothermal nucleic acid amplification qSTAR H HCP (150KB)
Patient (137KB)
IFU (1.57MB)
  • None currently
 None
08/11/2020 08/11/2020 Biomeme, Inc. Biomeme SARS-CoV-2 Real-Time RT-PCR Test (147KB) Molecular Real-time RT-PCR H HCP (150KB)
Patient (138KB)
IFU (2.63MB)
  • None currently
 None
08/13/2020 08/13/2020 Pro-Lab Diagnostics Pro-AmpRT SARS-CoV-2 Test (131KB) Molecular RT, Isothermal amplification H HCP (115KB)
Patient (104KB)
EUA Summary (179KB)
  • None currently
 None
08/15/2020 12/16/2020 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect (153KB) (Reissued December 16, 2020) Molecular Real-time RT-PCR, Saliva H HCP (159KB)
Patients (148KB)
EUA Summary (157KB)		 None
08/17/2020 08/17/2020 ZhuHai Sinochips Bioscience Co., Ltd. COVID-19 Nucleic Acid RT-PCR Test Kit (169KB) Molecular Real-time RT-PCR H  HCP (158KB)
Patients (142KB)
IFU (913KB)
  • None currently
 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 currently
 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 currently
 None
08/18/2020 08/18/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test (137KB) Antigen Microfluidic Immunofluorescence Assay, Instrument Read H, M, W HCP (142KB)
Patients (131KB)
IFU (11.92MB)
  • None currently
 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) Molecular Real-time RT-PCR H HCP (105KB)
Patients (94KB)
EUA Summary (194KB)
  • None currently
 None
08/21/2020 12/09/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT-PCR Test (98KB) Molecular Real-time RT-PCR, Saliva H HCP (140KB)
Patients (125KB)
EUA Summary (152KB)		 None
08/21/2020 08/21/2020 Guardant Health, Inc. Guardant-19 (104KB) Molecular Sequencing H HCP (105KB)
Patients (94KB)
EUA Summary (337KB)
  • None currently
 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 currently
 None
08/25/2020 11/05/2020 Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay (330KB) Molecular 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 currently
 None
08/26/2020 08/26/2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card (148KB) (Reissued December 16, 2020) Antigen Lateral Flow, Visual Read H, M, W HCP (162KB)
Patients (151KB)
IFU (1.23MB)
  • None currently
 None
08/26/2020 10/02/2020 Cuur Diagnostics  Cuur Diagnostics SARS-CoV-2 Molecular Assay (110KB) (Reissued October 2, 2020) Molecular Real-time RT-PCR H HCP (158KB)
Patients (146KB)
EUA Summary (106KB)
  • None currently
 None
08/28/2020 08/28/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT PCR CE Test (299KB) Molecular RT-PCR, Home Collection, Screening, Saliva H HCP (143KB)
Patients (130KB)
EUA Summary (1.19MB)
IFU (Home Collect) (2.5MB)
  • None currently
 None
08/28/2020 09/21/2020 Patients Choice Laboratories, LLC PCL SARS-CoV-2 Real-Time RT-PCR Assay (280KB) Molecular Real-time RT-PCR H HCP (105KB)
Patients (94KB)
EUA Summary (166KB)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
08/31/2020 08/31/2020 BayCare Laboratories, LLC BayCare SARS-CoV-2 RT PCR Assay (289KB) Molecular Real-time RT-PCR, Pooling H HCP (86KB)
Patients (92KB)
EUA Summary (444KB)
  • None currently
 None
08/31/2020 08/31/2020 Mammoth Biosciences, Inc. SARS-CoV-2 DETECTR Reagent Kit (313KB) Molecular RT-LAMP, CRISPR H HCP (141KB)
Patients (129KB)
IFU (461KB)
  • None currently
 None
08/31/2020 08/31/2020 MiraDx MiraDx SARS-CoV-2 RT-PCR assay (294KB) Molecular Real-time RT-PCR H HCP (105KB)
Patients (95KB)
EUA Summary (438KB)
  • None currently
 None
08/31/2020 10/22/2020 T2 Biosystems, Inc. T2SARS-CoV-2 Panel (314KB) Molecular RT, amplification, T2 Magnetic resonance H, M HCP (137KB)
Patients (124KB)
IFU (1.26MB)
  • None currently
 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 currently
 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 currently
 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   EUA Summary (142KB)
IFU (105KB)
  • None currently
 None
09/01/2020 09/01/2020 OPTOLANE Technologies, Inc. Kaira 2019-nCoV Detection Kit (141KB) Molecular Real-time RT-PCR H HCP (153KB)
Patients (141KB)
IFU (3.56MB)
  • None currently
 None
09/01/2020 10/06/2020 Detectachem Inc. MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit (147KB) (Reissued October 2, 2020) Molecular RT, LAMP H, M HCP (155KB)
Patients (143KB)
IFU (829KB)
  • None currently
 None
09/02/2020 12/09/2020 Bioeksen R&D Technologies Ltd. Bio-Speedy Direct RT-qPCR SARS-CoV-2 (126KB) Molecular Real-time RT-PCR H HCP (145KB)
Patients (133KB)
IFU (999KB)		 BioeXsen SARS-CoV-2 RT PCR
09/03/2020 12/15/2020 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B (155KB) Molecular Real-time RT-PCR, Multi-analyte H, M HCP (100KB)
Patients (155KB)
IFU (2.18MB)		 None
09/03/2020 09/03/2020 Sugentech, Inc. SGTi-flex COVID-19 IgG (138KB) Serology IgG, Lateral Flow H, M  HCP (152KB)
Recipients (138KB)
IFU (492KB)
  • None currently
 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 currently
 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 currently
 None
03/31/2020 06/04/2020 Yale New Haven Hospital, Clinical Virology Laboratory

SARS-CoV-2 PCR test (72KB)

 

 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 currently
 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 currently
 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 currently
 None
04/06/2020 10/15/2020 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay (119KB) (Reissued October 15, 2020)  Molecular Real-time RT-PCR, Home Collection, Pooling H HCP (147KB)
Patients (135KB)
EUA Summary (313KB)
  • None currently
 None
04/08/2020 11/24/2020 Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 RT-PCR Assay (117KB) Molecular, Real-time RT-PCR, Home Collection Kit H
HCP (148KB)
Patients (135KB)
EUA Summary (185KB)
IFU (Home Collection) (6.41MB)
  • None currently
 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 currently
 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 currently
 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)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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 currently
 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 currently
 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)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 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)
  • On September 21, 2020 this EUA’s IFU or EUA Summary was reposted to include results of testing with the FDA SARS-CoV-2 Reference Panel. Please also see SARS-CoV-2 Reference Panel Comparative Data for additional information.
 None
04/20/2020 07/29/2020 Mayo Clinic Laboratories, Rochester, MN

SARS-CoV-2 Molecular Detection Assay (68KB)

 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 currently
 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 currently
 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 currently
 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 currently
 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 currently
 None
04/30/2020 06/04/2020 Altru Diagnostics, Inc.

Altru Dx SARS-CoV-2 RT-PCR assay (78KB)

 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 currently
 None
05/03/2020 07/22/2020 UTMG Pathology Laboratory

UTHSC/UCH SARS-CoV-2-RT-PCR Assay (218KB)

 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 currently
 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 currently
 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 currently
 None
05/22/2020 11/19/2020 Express Gene LLC (dba Molecular Diagnostics Laboratory) Express Gene 2019-nCoV RT-PCR Diagnostic Panel (109KB) Molecular, Real-time RT-PCR, Collection Kit H HCP (161KB)
Patients (145KB)
EUA Summary (221KB)
IFU (373KB)
  • None currently
 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 currently
 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 currently
 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 currently
 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 currently
 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 currently
 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 currently
 None

1 Settings for use include the following:

  • H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §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. §263a, that meet requirements to perform moderate complexity tests. 
  • 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

4 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 FAQ 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.)

Date of First EUA Issuance Most Recent Letter of Authorization (PDF) Appendix (PDF) Authorized Labeling (PDF) Federal Register Notice for EUA EUA Determination and Declaration (Effective Date)
12/04/2020 Ecolab's Bioquell Technology System (128KB)  
  • None currently
  • None currently
12/03/2020 Lumin LM3000 Bioburden Reduction UV System (100KB)  
  • None currently
  • None currently
10/20/2020 Roxby Development Zoe-Ann Decontamination System (88KB)  
  • None currently
  • None currently
03/02/2020 NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency (232KB) (Reissed 03/27/2020 and 03/28/2020)  

Manufacturers of authorized respirators do not need to submit attestation to the FDA to request authorization.

Strategic stockpilers of authorized expired filtering facepiece respirators (FFRs) do not need to submit a request to the FDA to request authorization.
03/24/2020 Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (159KB) (Reissued June 6, 2020)  
04/03/2020 Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (87KB) (Reissued October 15, 2020, 2020)  
04/09/2020 Face Shields (209KB) (Reissued 04/13/2020)    
04/14/2020 Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle (272KB) (Reissued June 6, 2020)  
04/11/2020 Advanced Sterilization Products (ASP) STERRAD Sterilization System (314KB) (Reissued June 6, 2020)  
04/09/2020 STERIS Sterilization Systems for Decontamination of N95 Respirators (279KB) (Reissued June 6, 2020)  
03/29/2020 Battelle Decontamination System (248KB) (Reissued June 6, 2020)  
04/20/2020 Sterilucent, Inc. Sterilization System (2477KB) (Reissued June 6, 2020)  
05/07/2020 Duke Decontamination System (284KB) (Reissued June 6, 2020)  
05/19/2020 COVID-19 Airway Management Isolation Chamber (CAMIC) (99KB)
(Reissued June 22, 2020)		  
05/21/2020 STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers (293KB)  
05/22/2020 Gowns and Other Apparel (310KB)    
05/27/2020 Stryker Sustainability Solutions VHP Decontamination System (248KB) (Reissued June 6, 2020)  
06/13/2020 Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100) (103KB)  
06/13/2020 Technical Safety Services VHP Decontamination System (79KB)  
07/24/2020 Airway Dome (103KB)  
07/24/2020 Michigan State University Decontamination System (103KB)  
08/05/2020 Surgical Masks (101KB) Appendix A: Authorized Surgical Masks (updated October 28, 2020)
08/20/2020 Nova2200 for Decontaminating Compatible N95 Respirators (258KB)  
09/24/2020 COVIAGE (104KB)  
  • None currently
  • None currently

 

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.

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.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

Date EUA First Issued Device Type Most Recent Letter of Authorization (PDF) Appendix to Letter and Other Documents (PDF) Fact Sheets (PDF) Federal Register Notice for EUA
11/21/2020 Extracorporeal Membrane Oxygenation Terumo Cardiovascular CAPIOX Emergency Bypass System (363KB)
  • None currently
03/24/2020 Ventilators Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories (359KB)
04/09/2020 Extracorporeal Blood Purification (EBP) Terumo BCT Inc. and Marker Therapeutics AG Extracorporeal Blood Purification (EBP) Devices (268KB)
04/10/2020 Extracorporeal Blood Purification (EBP) CytoSorbents, Inc. Extracorporeal Blood Purification (EBP) Device (422KB)
04/11/2020 Infusion Pump B. Braun Space and Outlook Pumps (148KB)  
04/13/2020 Diaphragmatic Pacing Therapy System (DPTS) Synapse Biomedical, Inc. TransAeris Diaphragmatic Pacing Therapy System (DPTS) (422KB)
04/14/2020 Diaphragmatic Pacing Therapy System (DPTS) Lungpacer Medical, Inc. Diaphragm Pacing Therapy System (DPTS) (154KB)
04/17/2020 Extracorporeal Blood Purification (EBP) ExThera Medical Corporation Extracorporeal Blood Purification (EBP) Device (280KB)
04/18/2020 Face Masks Face Masks (non-surgical) (91KB) (Reissued 04/24/2020)  
04/21/2020 Remote Patient Monitor IntelliVue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (98KB)
04/22/2020 Extracorporeal Blood Purification (EBP) Baxter Healthcare Corporation Extracorporeal Blood Purification (EBP) Device (744KB)
04/22/2020 Respiratory Assist Device ALung Technologies, Inc., Hemolung RAS (355KB)
04/26/2020 Remote Patient Monitor VitalConnect, Inc., VitalPatch (106KB)
04/30/2020 Continuous Renal Replacement Therapy (CRRT) Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions 1 (171KB)
05/01/2020 Respiratory Muscle Stimulator Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device (347KB)
05/05/2020 Remote Patient QT Interval Monitor PhysiolGuard, ECG-QT Analysis System (109KB)
05/08/2020 Patient Isolation Transport Unit (PITU) Patient Isolation Transport Unit (PITU) Device (400KB)
05/11/2020 LVEF Screen Eko Devices, Inc, ELEFT (379KB)
05/11/2020 Nurse Call System Ascom (US), Inc., teleCARE (357KB)
05/14/2020 Remote Patient QT Interval Monitor G Medical Innovations, Ltd., VSMS Patch (107KB)
05/20/2020 CRRT Set Baxter Healthcare Corporation, Prismaflex ST Set (355KB)
05/26/2020 Predictive Screening CLEW Medical Ltd., CLEWICU System (105KB)
05/29/2020 Right Ventricular Assist Catheter Abiomed, Inc., Impella RP System (142KB)
07/10/2020 Non-Invasive Vagus Nerve Stimulator electroCore, Inc., gammaCore Sapphire CV (367KB)
08/03/2020 Left Ventricular Support System Abiomed, Inc., Impella LV Systems (165KB)
08/10/2020 CRRT Set Baxter Healthcare Corporation, Prismaflex HF20 Set (96KB)
09/24/2020 Predictive Screening COViage Hemodynamic Instability and Respiratory Decompensation Prediction System (COViage), Dascena, Inc. (112KB)
  • None currently

1 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The  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.

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.

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)
12/11/2020 Pfizer-BioNTech COVID-19 Vaccine (421KB) For the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older

Healthcare Providers (1.16MB)

Recipients and Caregivers (197KB)

Decision Memorandum (709KB)

Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine

More information about the Pfizer-BioNTech COVID-19 Vaccine
  • None currently
 Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020)
11/21/2020 Casirivimab and Imdevimab (375KB) Casirivimab and imdevimab to be administered together for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Heathcare Providers (435KB)

Patients, Parents, and Caregivers (110KB)

Dear Heathcare Provider Letter (1.09MB)

Information Sheet (“Fact Sheet Directions”) (46KB)

Frequently Asked Questions on the Emergency Use Authorization of Casirivimab + Imdevimab (324KB)

CDER Review Document (3.60MB)
  • None currently
 Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020)
11/19/2020 Baricitinib (Olumiant) in Combination with remdesivir (Veklury) (322KB) For emergency use by healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Healthcare Providers (155KB)

Patients, Parents, and Caregivers (55KB)

Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) in Combination with Veklury (remdesivir) for Treatment of Mild to Moderate COVID-19 (270KB)

CDER Review Document (1.39MB)
  • None currently
 Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020)
11/09/2020 Bamlanivimab (374KB) 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 Providers (528KB)

Patients, Parents, and Caregivers (127KB)

Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab (250KB)

CDER Review Document (2.28MB)
  • None currently
 Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020)
08/23/2020 COVID-19 convalescent plasma (302KB) (Reissued November 30, 2020) For the treatment of hospitalized patients with Coronavirus Disease 2019 (COVID-19)

Healthcare Providers (222KB)

Patients and Parents/ Caregivers (142KB)

Summary Information 9/23/2020 (380KB)

Decision Memorandum (505KB)

Emergency Use Authorization request (510KB)
  • None currently
 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)
  • None currently
 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% (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 2  Healthcare Providers (288KB)

Patients and Parent/Caregivers (39KB)

Propoven 2% Wall Chart (2.4MB)
  • None currently
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 Patients (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  with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved  drugs used for their treatment, such as propofol for sedation of mechanically ventilated patients.  

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.

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Other Current EUAs

The tables below provide information on current EUAs:

Information about EUAs that are no longer in effect is available on our EUA archive page.

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