U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Emergency Use Authorizations for Medical Devices
  6. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
  7. In Vitro Diagnostics EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs

In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:

  • Diagnostic Tests - Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
  • Serology/Antibody Tests - Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection.
  • Tests for Management of COVID-19 Patients - Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.

Any test developer requesting an EUA that intends to leverage data from another EUA-authorized device must obtain a right of reference to leverage the performance data for that EUA-authorized device. The Centers for Disease Control and Prevention (CDC) has granted a right of reference to the performance data contained in CDC's EUA request (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:

These templates are part of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff, which also includes additional policies specific to this public Health emergency. The templates reflect FDA's current thinking on the data and information that developers should submit to facilitate the EUA process. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about the COVID-19 disease and gain experience with the EUA process for the various types of COVID-19 tests.

Developers who intend to use alternative approaches should consider seeking the FDA's feedback or recommendations to help them through the EUA process. The FDA encourages developers to discuss any alternative technological approaches to validating their test with the FDA through CDRH-EUA-Templates@fda.hhs.gov.

Members of the public can submit questions about the templates to CDRH-EUA-Templates@fda.hhs.gov, or they can submit comments regarding the templates to the public docket established for the guidance Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.

Test developers interested in pursuing an EUA may submit a pre-EUA to begin discussions with the FDA or may submit an EUA request to CDRH-EUA-Templates@fda.hhs.gov.

Additional information can be found on the FAQs on Testing for SARS-CoV-2 webpage.

Tables of IVD EUAs:


Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2

This table includes information about authorized SARS-CoV-2 molecular diagnostic tests. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. 

Date EUA Issued or Last Updated Entity Diagnostic (Most Recent Letter of Authorization) and Date EUA Original Issue Attributes3 Authorized Setting(s)1 Authorization Documents2 Other Documents Other Brand Name(s)
09/01/2020 SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit
04/27/2020
Real-time RT-PCR H HCP, Patients, IFU None
04/23/2020 SD Biosensor, Inc. STANDARD M nCoV Real-Time Detection Kit
04/23/2020
Real-time RT-PCR H HCP, Patients, IFU None None
04/22/2020 altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S.
04/22/2020
Real-time RT-PCR H HCP, Patients, IFU None None
07/13/2020 Centers for Disease Control and Prevention's (CDC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
02/04/2020
Real-time RT-PCR H HCP, Patients, IFU None
03/15/2020 Wadsworth Center, New York State Department of Public Health's (CDC) New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel
02/29/2020
Real-time RT-PCR H HCP, Patients, IFU None
04/24/2020 BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2
03/26/2020
Real-time RT-PCR H HCP, Patients, IFU None
09/21/2020 Cepheid Xpert Xpress SARS-CoV-2 test
03/20/2020
Real-time RT-PCR H, M, W HCP, Patients, IFU for Labs,
IFU for Point-of-Care
None
04/08/2020 Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
03/20/2020
Real-time RT-PCR H HCP, Patients, IFU None
08/18/2020 GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test
03/19/2020
RT-PCR and electrochemical detection H, M HCP, Patients, IFU None
06/04/2020 DiaSorin Molecular LLC Simplexa COVID-19 Direct assay
03/19/2020
Real-time RT-PCR H, M HCP, Patients, IFU None
07/30/2020 Abbott Molecular Abbott RealTime SARS-CoV-2 assay
03/18/2020
Real-time RT-PCR H HCP, Patients, IFU None
09/21/2020 Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR
03/17/2020
Real-time RT-PCR, Home Collection, Pooling H HCP, Patients, IFU, IFU (Home Collect) None
04/08/2020 Quidel Corporation Lyra SARS-CoV-2 Assay
03/17/2020
Real-time RT-PCR H HCP, Patients, IFU None
09/18/2020 Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test
03/16/2020
Real-time RT-PCR, Home Collection, Pooling, Screening H HCP, Patients, EUA
Summary
, IFU (Pixel Home Collect), IFU LabCorp Home Collect
None
09/23/2020 Hologic, Inc. Panther Fusion SARS-CoV-2 Assay
03/16/2020
Real-time RT-PCR, Pooling, Screening H HCP, Patients, IFU None
10/16/2020 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
03/13/2020
Real-time RT-PCR, Home Collection H HCP, Patients, IFU None
10/15/2020 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2
03/12/2020
Real-time RT-PCR, Pooling H, M, H-Pooling HCP, Patients, IFU None
08/24/2020 Mesa Biotech Inc. Accula SARS-Cov-2 Test
03/23/2020
RT and amplification H, M, W HCP, Patients, IFU None
04/30/2020 BioFire Defense, LLC BioFire COVID-19 Test
03/23/2020
RT, Nested multiplex PCR H, M HCP, Patients, IFU None
09/25/2020 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit
03/24/2020
Real-time RT-PCR H HCP, Patients, IFU None
09/25/2020 Avellino Lab USA, Inc. AvellinoCoV2 test
03/25/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None
03/27/2020 Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay
03/27/2020
RT-PCR H HCP, Patients, IFU None None
09/17/2020 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19
03/27/2020
RT, Isothermal amplification H, M, W HCP, Patients, IFU None
09/21/2020 QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel
03/30/2020
Real-time RT-PCR, Multi-analyte H, M HCP, Patients, IFU None None
04/23/2020 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay
03/30/2020
RT-PCR H, M HCP, Patients, IFU None
04/01/2020 Ipsum Diagnostics, LLC COV-19 IDx assay
04/01/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/22/2020 Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System
04/02/2020
Real-time RT-PCR H, M HCP, Patients, IFU None
04/03/2020 Co-Diagnostics, Inc. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
04/03/2020
RT-PCR, CoPrimer technology H HCP, Patients, IFU None None
09/22/2020 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
04/03/2020
Real-time RT-PCR H HCP, Patients, IFU None
05/11/2020 Luminex Corporation ARIES SARS-CoV-2 Assay
04/03/2020
RT-PCR H, M HCP, Patients, IFU None
04/28/2020 Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit
04/06/2020
Real-time RT-digital PCR H HCP, Patients, IFU None
10/02/2020 InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR Kit
04/07/2020
Real-time RT-PCR H HCP, Patients, IFU None
04/08/2020 DiaCarta, Inc QuantiVirus SARS-CoV-2 Test kit
04/08/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/23/2020 Becton, Dickinson & Company BD SARS-CoV-2Reagents for BD MAX System
04/08/2020
Real-time RT-PCR H, M HCP, Patients, IFU None
07/18/2020 Atila BioSystems, Inc. iAMP COVID-19 Detection Kit
04/10/2020
RT, Isothermal amplification H HCP, Patients, IFU None
04/15/2020 Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit
04/15/2020
Real-time RT-PCR H HCP, Patients, IFU None None
06/11/2020 KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay
04/16/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None
04/16/2020 GenoSensor, LLC GS"¢ COVID-19 RT-PCR KIT
04/16/2020
Real-time RT-PCR H HCP, Patients, IFU None None
04/17/2020 Fosun Pharma USA Inc. Fosun COVID-19 RT-PCR Detection Kit
04/17/2020
Real-time RT-PCR H HCP, Patients, IFU None None
04/18/2020 OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit
04/18/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/08/2020 Trax Management Services Inc. PhoenixDx 2019-CoV
04/20/2020
Real-time RT-PCR H HCP, Patients, IFU None
07/27/2020 Seegene, Inc. Allplex 2019-nCoV Assay
04/21/2020
Real-time RT-PCR H HCP, Patients, IFU None
09/22/2020 LabGenomics Co., Ltd. LabGun COVID-19 RT-PCR Kit
04/29/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/21/2020 Rheonix, Inc. Rheonix COVID-19 MDx Assay
04/29/2020
RT-PCR H HCP, Patients, IFU None None
09/18/2020 Bio-Rad Laboratories, Inc Bio-Rad SARS-CoV-2 ddPCR Test
05/01/2020
RT-droplet PCR H HCP, Patients, IFU None None
05/01/2020 BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1)
05/01/2020
RT, Nested multiplex PCR, Multi-analyte H, M HCP, Patients, IFU None None
05/04/2020 Sansure BioTech Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
05/04/2020
Real-time RT-PCR H HCP, Patients, IFU None None
07/09/2020 Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) FTD SARS-CoV-2
05/05/2020
Real-time RT-PCR H HCP, Patients, IFU None
07/29/2020 OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test
05/06/2020
Real-time RT-PCR H HCP, Patients, IFU None
09/21/2020 Sherlock BioSciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit
05/06/2020
RT-LAMP, CRISPR H HCP, Patients, IFU None None
05/06/2020 BioMérieux SA SARS-COV-2 R-GENE
05/06/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/18/2020 Infinity BiologiX LLC Infinity BiologiX TaqPath SARS-CoV-2 Assay
04/10/2020
Real-time RT-PCR, Home Collection, Saliva H

HCP, Patients, IFU (Home Collect), EUA Summary

None
  • 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
05/28/2020 Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit
05/07/2020
Real-time RT-PCR H HCP, Patients, IFU None
05/08/2020 Gnomegen LLC Gnomegen COVID-19-RT-qPCR Detection Kit
05/08/2020
Real-time RT-PCR H HCP, Patients, IFU None None
05/11/2020 1drop Inc. 1copy COVID-19 qPCR Multi Kit
05/11/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/24/2020 Abbott Molecular Inc. Alinity m SARS-CoV-2 assay
05/11/2020
Real-time RT-PCR H, M HCP, Patients, IFU None
09/21/2020 Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit
05/13/2020
Real-time RT-PCR H HCP, Patients, IFU None
10/05/2020 Hologic, Inc. Aptima SARS-CoV-2 assay
05/14/2020

TMA, chemiluminescent

H HCP, Patients, IFU None
09/21/2020 GeneMatrix, Inc. NeoPlex COVID-19 Detection Kit
05/14/2020
Real-time RT-PCR H HCP, Patients, IFU None None
06/15/2020 Fulgent Therapeutics, LLC Fulgent COVID-19 by RT-PCR Test
05/15/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None
09/04/2020 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit
05/15/2020
Home Collection Kit N/A IFU, EUA Summary None
09/21/2020 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel
05/15/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
05/18/2020 Quidel Corporation Lyra Direct SARS-CoV-2 Assay
05/18/2020
Real-time RT-PCR H HCP, Patients, IFU

None

None
07/10/2020 P23 Labs, LLC. P23 Labs TaqPath SARS-CoV-2 Assay
05/21/2020
Real-time RT-PCR, Home Collection, Saliva H HCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect)  EUA Summary None
05/21/2020 Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit
05/21/2020
RT-LAMP H HCP, Patients, IFU None None
05/21/2020 SolGent Co., Ltd DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
05/21/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/21/2020 BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit
05/21/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/11/2020 dba SpectronRX Hymon SARS-CoV-2 Test Kit
05/22/2020
Real-time RT-PCR H HCP, Patients, IFU None
08/14/2020 PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus (COVID-19) Test
05/28/2020
TMA, chemiluminescent, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None
09/21/2020 Gravity Diagnostics, LLC Gravity Diagnostics COVID-19 Assay
06/01/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary None
06/24/2020 Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test
06/04/2020
Real-time RT-PCR, Home Collection, Saliva H HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic) None
06/05/2020 Genetron Health (Beijing) Co., Ltd. Genetron SARS-CoV-2 RNA Test
06/05/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/21/2020 Euroimmun US, Inc. EURORealTime SARS-Cov-2
06/08/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/20/2020 Illumina, Inc. Illumina COVIDSeq Test
06/09/2020
Sequencing H HCP, Patients, IFU None
09/21/2020 ChromaCode Inc. HDPCR SARS-CoV-2 Assay
06/09/2020
Real-time RT-PCR H HCP, Patients, IFU None None
06/10/2020 Tide Laboratories, LLC DTPM COVID-19 RT-PCR Test
06/10/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/10/2020 TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit
06/10/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/20/2020 Cue Health Inc. Cue COVID-19 Test
06/10/2020
RT, Isothermal amplification H, M, W HCP, Patients, IFU None
06/12/2020 RTA Laboratories Biological Products Pharmaceutical and Machinery Industry Diagnovital SARS-CoV-2 Real-Time PCR Kit
06/12/2020
Real-time RT-PCR H HCP, Patients, IFU None None
06/15/2020 Applied BioCode, Inc. BioCode SARS-CoV-2 Assay
06/15/2020
RT-PCR H HCP, Patients, IFU None None
09/09/2020 Kaiser Permanente Mid-Atlantic States KPMAS COVID-19 Test
06/13/2020
Real-time RT-PCR, Home Collection, Screening H HCP, Patients, EUA SummaryIFU (Home Collect) None None
06/18/2020 Jiangsu Bioperfectus Technologies Co., Ltd. COVID-19 Coronavirus Real Time PCR Kit
06/18/2020
Real-time RT-PCR H HCP, Patients, IFU None None
06/17/2020 The Ohio State University Wexner Medical Center OSUWMC COVID-19 RT-PCR test
06/17/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/17/2020 Omnipathology Solutions Medical Corporation Omni COVID-19 Assay by RT-PCR
06/17/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
07/21/2020 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. TRUPCR SARS-CoV-2 Kit
06/18/2020
Real-time RT-PCR H HCP, Patients, IFU None
09/21/2020 HealthQuest Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay
06/23/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/23/2020 University of Alabama at Birmingham Fungal Reference Lab FRL SARS CoV-2 Test
06/23/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/23/2020 Gencurix, Inc. GenePro SARS-CoV-2 Test
06/23/2020
Real-time RT-PCR H HCP, Patients, IFU None None
06/24/2020 University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay
06/24/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/25/2020 Diagnostic Solutions Laboratory, LLC DSL COVID-19 Assay
06/25/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/25/2020 PreciGenome LLC FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)
06/25/2020
RT-digital droplet PCR H HCP, Patients, IFU None None
06/25/2020 PlexBio Co., Ltd. IntelliPlex SARS-CoV-2 Detection Kit
06/25/2020
RT-PCR H HCP, Patients, IFU None None
06/26/2020 Inform Diagnostics, Inc. Inform Diagnostics SARS-CoV-2 RT-PCR Assay
06/26/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/29/2020 LifeHope Labs LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel
06/29/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/24/2020 Acupath Laboratories, Inc. Acupath COVID-19 Real-Time (RT-PCR) Assay
06/29/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/21/2020 Psomagen, Inc. Psoma COVID-19 RT Test
06/30/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
06/30/2020 TNS Co., Ltd (Bio TNS) COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit
06/30/2020
RT-PCR H HCP, Patients, IFU None None
06/30/2020 The Kroger Co. Kroger Health COVID-19 Test Home Collection Kit
06/30/2020
Home Collection Kit   IFU, EUA Summary None None
07/01/2020 CENTOGENE US, LLC CentoFast-SARS-CoV-2 RT-PCR Assay
07/01/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/21/2020 Centers for Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
07/02/2020
Real-time RT-PCR, Multi-analyte H HCP, Patients, IFU None None
07/06/2020 Laboratorio Clinico Toledo Laboratorio Clinico Toledo SARS-CoV-2 Assay
07/06/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
07/07/2020 Enzo Life Sciences, Inc. AMPIPROBE SARS-CoV-2 Test System
07/07/2020
Real-time RT-PCR H HCP, Patients, IFU None None
07/07/2020 Access Bio, Inc. CareStart COVID-19 MDx RT-PCR
07/07/2020
Real-time RT-PCR H HCP, Patients, IFU None None
07/07/2020 Gene By Gene Gene By Gene SARS-CoV-2 Detection Test
07/07/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/31/2020 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
07/08/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None
07/09/2020 UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin SARS-CoV-2 RNA DETECTR Assay
07/09/2020
RT-LAMP H HCP, Patients, EUA Summary None None
07/09/2020 BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit
07/09/2020
Real-time RT-PCR H HCP, Patients, IFU None None
07/10/2020 Boston Medical Center BMC-CReM COVID-19 Test
07/10/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/21/2020 KogeneBiotech Co., Ltd. PowerChek 2019-nCoV Real-time PCR Kit
07/13/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/08/2020 Trax Management Services Inc. PhoenixDx SARS-CoV-2 Multiplex
07/13/2020
Real-time RT-PCR H HCP, Patients, IFU None
07/13/2020 Compass Laboratory Services, LLC Compass Laboratory Services SARS-CoV2 Assay
07/13/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary None None
08/21/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics PF SARS-CoV-2 Assay
07/15/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
08/21/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics RC SARS-CoV-2 Assay
07/15/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
08/21/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics HA SARS-CoV-2 Assay
07/15/2020
TMA, chemiluminescent, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
09/21/2020 Boston Heart Diagnostics Boston Heart COVID-19 RT-PCR Test
07/16/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None
09/25/2020 Access Genetics, LLC OraRisk COVID-19 RT-PCR
07/17/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
07/21/2020 DiaCarta, Inc. QuantiVirus SARS-CoV-2 Multiplex Test Kit
07/21/2020
Real-time RT-PCR H HCP, Patients, IFU None None
07/23/2020 Helix OpCo LLC (dba Helix) Helix COVID-19 Test
07/23/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
07/24/2020 Jiangsu CoWin Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
07/24/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/22/2020 Color Genomics, Inc. Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay
05/18/2020
RT, LAMP, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect), IFU (On-site Collect) None
09/21/2020 Eli Lilly and Company Lilly SARS-CoV-2 Assay
07/27/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None
07/27/2020 Sandia National Laboratories SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay
07/27/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
07/30/2020 Clinical Reference Laboratory, Inc. CRL Rapid Response
07/30/2020
Real-time RT-PCR, Home Collection, Saliva H

HCP, Patients, EUA Summary, IFU (Home Collect)

None None
07/31/2020 Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit (Real-time PCR)
07/31/2020
Real-time RT-PCR H HCP, Patients, IFU None None
07/31/2020 University of California San Diego Health UCSD RC SARS-CoV-2 Assay
07/31/2020
Real-time RT-PCR, Pooling H HCP, Patients, EUA Summary None None
08/03/2020 Wren Laboratories LLC Wren Laboratories COVID-19 PCR Test
08/03/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/21/2020 Ethos Laboratories Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
08/03/2020
RT-PCR and MALDI-TOF Mass Spec. H HCP, Patients, EUA Summary, IFU (Home Collect) None
08/03/2020 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute Cleveland Clinic SARS-CoV-2 Assay
08/03/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/03/2020 Poplar Healthcare Poplar SARS-CoV-2 TMA Pooling assay
08/03/2020
TMA, chemiluminescent, Pooling H HCP, Patients, EUA Summary None None
09/21/2020 Exact Sciences Laboratories SARS-CoV-2 (N gene detection) Test
05/22/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect None
08/03/2020 ISPM Labs, LLC dba Capstone Healthcare Genus SARS-CoV-2 Assay
08/03/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/06/2020 Helix OpCo LLC (dba Helix) Helix COVID-19 NGS Test
08/06/2020
Sequencing H HCP, Patients, EUA Summary None None
08/05/2020 Vela Operations Singapore Pte Ltd ViroKey SARS-CoV-2 RT-PCR Test
08/05/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/07/2020 George Washington University Public Health Laboratory GWU SARS-CoV-2 RT-PCR Test
08/07/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/10/2020 Solaris Diagnostics Solaris Multiplex SARS-CoV-2 Assay
08/10/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/10/2020 Alpha Genomix Laboratories Alpha Genomix TaqPath SARS-CoV-2 Combo Assay
08/10/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/11/2020 Biomeme, Inc. Biomeme SARS-CoV-2 Real-Time RT-PCR Test
08/11/2020
Real-time RT-PCR H HCP, Patient, IFU None None
08/11/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR
08/11/2020
RT, non-isothermal nucleic acid amplification qSTAR H HCP, Patient, IFU None None
08/13/2020 Pro-Lab Diagnostics Pro-AmpRT SARS-CoV-2 Test
08/13/2020
RT, Isothermal amplification H HCP, Patient, EUA Summary None None
10/15/2020 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect
08/15/2020
Real-time RT-PCR, Saliva H HCP, Patients, EUA Summary None
08/17/2020 ZhuHai Sinochips Bioscience Co., Ltd. COVID-19 Nucleic Acid RT-PCR Test Kit
08/17/2020
Real-time RT-PCR H HCP, Patients, IFU None None
08/21/2020 Guardant Health, Inc. Guardant-19
08/21/2020
Sequencing H HCP, Patients, EUA Summary None None
08/21/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT-PCR Test
08/21/2020
Real-time RT-PCR, Saliva H HCP, Patients, EUA Summary None None
08/21/2020 Texas Department of State Health Services, Laboratory Services Section Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay
08/21/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/21/2020 Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
08/25/2020
Real-time RT-PCR, Saliva H HCP, Patients, IFU None None
08/25/2020 QDx Pathology Services QDX SARS-CoV-2 Assay
08/25/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
10/02/2020 Cuur Diagnostics Cuur Diagnostics SARS-CoV-2 Molecular Assay
08/26/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/21/2020 Patients Choice Laboratories, LLC PCL SARS-CoV-2 Real-Time RT-PCR Assay
08/28/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/28/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT PCR CE Test
08/28/2020
Real-time RT-PCR, Home Collection, Screening, Saliva H HCP, Patients, EUA Summary, IFU (Home Collect) None None
08/31/2020 T2 Biosystems, Inc. T2SARS-CoV-2 Panel
08/31/2020
RT, amplification, T2 Magnetic resonance H HCP, Patients, IFU None None
08/31/2020 MiraDx MiraDx SARS-CoV-2 RT-PCR assay
08/31/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
08/31/2020 Mammoth Biosciences, Inc. SARS-CoV-2 DETECTR Reagent Kit
08/31/2020
RT-LAMP, CRISPR H HCP, Patients, IFU None None
08/31/2020 BayCare Laboratories, LLC BayCare SARS-CoV-2 RT PCR Assay
08/31/2020
Real-time RT-PCR, Pooling H HCP, Patients, EUA Summary None None
10/06/2020 Detectachem Inc. MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit
09/01/2020
RT-LAMP H, M HCP, Patients, IFU None None
09/01/2020 OPTOLANE Technologies, Inc. Kaira 2019-nCoV Detection Kit
09/01/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/15/2020 Color Genomics, Inc. Color COVID-19 Self-Swab Collection Kit
08/31/2020
Home Collection Kit   EUA Summary, IFU None None
09/02/2020 Bioeksen R&D Technologies Ltd. Bio-Speedy Direct RT-qPCR SARS-CoV-2
09/02/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/03/2020 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B
09/03/2020
Real-time RT-PCR, Multi-analyte H, M HCP, Patients, IFU None None
09/04/2020 BillionToOne, Inc. qSanger-COVID-19 Assay
09/04/2020
Sequencing H HCP, Patients, IFU None None
09/08/2020 Verily Life Sciences Verily COVID-19 RT-PCR Test
09/08/2020
Real-time RT-PCR, Pooling H HCP, Patients, EUA Summary None None
09/09/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 RT-PCR Kit
09/09/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/18/2020 Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
09/14/2020
Real-time RT-PCR, Multi-analyte H, M, W HCP, Patients, IFU None
09/16/2020 Visby Medical, Inc. Visby Medical COVID-19
09/16/2020
RT-PCR H, M HCP, Patients, IFU None None
09/18/2020 GK Pharmaceuticals Contract Manufacturing Operations GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT
09/18/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/21/2020 KimForest Enterprise Co., Ltd. KimForest SARS-CoV-2 Detection Kit v1
09/21/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/22/2020 Quadrant Biosciences Inc. Clarifi COVID-19 Test Kit
09/22/2020
Real-time RT-PCR, Saliva H HCP, Patients, IFU None None
09/22/2020 Vela Operations Singapore Pte. Ltd. ViroKey SARS-CoV-2 RT-PCR Test v2.0
09/22/2020
Real-time RT-PCR H HCP, Patients, IFU None None
09/23/2020 Clear Labs, Inc. Clear Dx SARS-CoV-2 Test
09/23/2020
RT-PCR and Sequencing H HCP, Patients, IFU None None
09/24/2020 Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV
09/24/2020
Real-time RT-PCR, Multi-analyte H, M, W HCP, Patients, IFU for Labs, IFU for Point-of-Care None None
10/17/2020 Genetrack Biolabs, Inc. Genetrack SARS-CoV-2 Molecular Assay
09/25/2020
Real-time RT-PCR H HCP, Patients, EUA Summary, IFU (Home Collect) None
09/30/2020 Aeon Global Health Aeon Global Health SARS-CoV-2 Assay
09/30/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/29/2020 CENTOGENE US, LLC CentoSure SARS-CoV-2 RT-PCR Assay
09/29/2020
Real-time RT-PCR, Screening H HCP, Patients, EUA Summary None None
09/29/2020 Akron Children’s Hospital Akron Children’s Hospital SARS-CoV-2 Assay
09/29/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
09/29/2020 National Jewish Health SARS-CoV-2 MassArray Test
09/29/2020
RT-PCR and MALDI-TOF Mass Spec. H HCP, Patients, EUA Summary None None
09/30/2020 Alimetrix, Inc. Alimetrix SARS-CoV-2 RT-PCR Assay
09/30/2020
RT-PCR, Microarray Hybridization H HCP, Patients, EUA Summary None None
10/01/2020 Tempus Labs, Inc. iC SARS-CoV2 Test
10/01/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
10/01/2020 UMass Memorial Medical Center UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel
10/01/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
10/02/2020 BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)
10/02/2020
RT, Nested multiplex PCR, Multi-analyte H, M, W HCP, Patients, IFU None None
10/05/2020 SEASUN BIOMATERIALS, Inc. AQ-TOP COVID-19 Rapid Detection Kit PLUS
10/05/2020
RT-LAMP H HCP, Patients, IFU None None
10/08/2020 University of California, Los Angeles (UCLA) UCLA SwabSeq COVID-19 Diagnostic Platform
10/06/2020
RT-PCR and Sequencing H HCP, Patients, EUA Summary None None
10/07/2020 GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2
10/07/2020
RT-PCR and electrochemical detection, Multi-analyte H, M HCP, Patients, IFU None None
10/16/2020 Spectrum Solutions LLC SDNA-1000 Saliva Collection Device
10/08/2020
Saliva Collection Device N/A EUA Summary, IFU None None
10/14/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR Complete
10/14/2020
RT, qSTAR amplification H HCP, Patients, IFU None None
10/15/2020 Clinical Enterprise, Inc. EmpowerDX At-Home COVID-19 PCR Test Kit
10/15/2020
Home Collection Kit N/A EUA Summary, IFU None None
10/15/2020 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay 04/06/2020 Real-Time RT-PCR, Home Collection, Pooling H HCP, Patients, EUA Summary None None

1 Authorized settings 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:

  • 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;

Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests

On March 31, 2020, the FDA issued an umbrella EUA for molecular laboratory developed tests (LDTs) for detection of SARS-CoV-2 that meet certain criteria for eligibility described in the EUA. Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. A manufacturer may request the addition of an eligible molecular-based LDT to Appendix A by submitting a request to CDRH-EUA-Templates@FDA.HHS.GOV.

The table below includes information for the high complexity molecular-based laboratory developed SARS-CoV-2 assays authorized by this Umbrella EUA during the COVID-19 public health emergency.  

Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2

Date EUA Issued or Last Updated Laboratory Letter Granting Inclusion under EUA and Original Issue Date EUA Summary Other Documents
06/04/2020 Altru Diagnostics, Inc. Altru Dx SARS-CoV-2 RT-PCR assay
04/30/2020
EUA Summary Letter Granting EUA Amendment(s) (June 4, 2020)
04/28/2020 Biocerna SARS-CoV-2 Test
04/28/2020
EUA Summary None
04/27/2020 Nationwide Children's Hospital SARS-CoV-2 Assay
04/27/2020
EUA Summary None
09/22/2020 Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test
04/22/2020
EUA Summary None
04/10/2020 Orig3n, Inc. Orig3n 2019 Novel Coronavirus (COVID-19) Test
04/10/2020
EUA Summary None
04/10/2020 Specialty Diagnostic (SDI) Laboratories SDI SARS-CoV-2 Assay
04/10/2020
EUA Summary None
04/08/2020 Stanford Health Care Clinical Virology Laboratory Stanford SARS-CoV-2 assay
04/08/2020
EUA Summary None
04/03/2020 Massachusetts General Hospital MGH COVID-19 qPCR assay
04/03/2020
EUA Summary None
04/02/2020 Diagnostic Molecular Laboratory - Northwestern Medicine SARS-Cov-2 Assay
04/02/2020
EUA Summary None
04/02/2020 Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia SARS-CoV-2 RT-PCR test
04/02/2020
EUA Summary None
06/04/2020 Yale New Haven Hospital,
Clinical Virology Laboratory
SARS-CoV-2 PCR test
03/31/2020
EUA Summary Letter Granting EUA Amendment(s) (June 4, 2020)
09/21/2020 University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR test
04/10/2020
EUA Summary None
04/13/2020 Integrity Laboratories SARS-CoV-2 Assay
04/13/2020
EUA Summary None
09/21/2020 Pathology/Laboratory Medicine Lab of Baptist Hospital Miami COVID-19 RT-PCR Test
04/13/2020
EUA Summary None
09/21/2020 Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital Childrens-Altona-SARS-CoV-2 Assay
04/14/2020
EUA Summary None
09/21/2020 Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory CDI Enhanced COVID-19 Test
04/15/2020
EUA Summary None
09/21/2020 CirrusDx Laboratories CirrusDx SARS-CoV-2 Assay
04/15/2020
EUA Summary None
04/14/2020 Exact Sciences Laboratories SARS-CoV-2 Test
04/14/2020
EUA Summary None
07/29/2020 Mayo Clinic Laboratories, Rochester, MN SARS-CoV-2 Molecular Detection Assay
04/20/2020
EUA Summary Letter Granting EUA Amendment(s) (July 29, 2020)
04/23/2020 Southwest Regional PCR Laboratory LLC. dba MicroGen DX COVID-19 Key
04/23/2020
EUA Summary None
04/24/2020 Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay
04/24/2020
EUA Summary None
04/24/2020 AIT Laboratories SARS-CoV-2 Assay
04/24/2020
EUA Summary None
07/22/2020 UTMG Pathology Laboratory UTHSC/UCH SARS-CoV-2-RT-PCR Assay
05/03/2020
EUA Summary Letter Granting EUA Amendment(s) (July 22, 2020)
05/07/2020 Biocollections Worldwide, Inc. Biocollections Worldwide SARS-Co-V-2 Assay
05/07/2020
EUA Summary None
09/14/2020 Columbia University Laboratory of Personalized Genomic Medicine TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST
05/12/2020
EUA Summary Letter Granting EUA Revision(s) (September 14, 2020)
05/13/2020 One Health Laboratories, LLC SARS-CoV-2 Real-Time RT-PCR-Test
05/13/2020
EUA Summary None
05/13/2020 Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine SARS-CoV-2-Assay
05/13/2020
EUA Summary None
06/01/2020 Aspirus Reference Laboratory Aspirus SARS-CoV rRT Assay
06/01/2020
EUA Summary None
06/04/2020 Nebraska Medicine Clinical Laboratory NEcov19 RT-PCR Assay
06/04/2020
EUA Summary None
06/01/2020 CSI Laboratories CSI SARS-CoV-2 RT PCR Test
06/01/2020
EUA Summary None
05/22/2020 Express Gene LLC (dba Molecular Diagnostics Laboratory) Express Gene 2019-nCoV RT-PCR Diagnostic Panel
05/22/2020
EUA Summary None
05/22/2020 Avera Institute for Human Genetics Avera Institute for Human Genetics SARS-CoV-2 Assay
05/22/2020
EUA Summary None
06/10/2020 Warrior Diagnostics, Inc. Warrior Diagnostics SARS-CoV-2 Assay
06/10/2020
EUA Summary None
06/12/2020 Cormeum Laboratory Services Cormeum SARS-CoV-2 Assay
06/12/2020
EUA Summary None

1 The tests listed in this table are all molecular-based tests for COVID-19 and the authorized setting is for use in the identified laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.


Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2

This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. 

Date EUA Issued or Last Updated Entity Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued Attributes Authorized Setting(s)1 Authorization Documents2 Other Documents Other Brand Name(s)
07/17/2020 Quidel Corporation Sofia SARS Antigen FIA
05/08/2020
Lateral Flow, Fluorescence, Instrument Read H, M, W HCP, Patients, IFU None
07/23/2020 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2
07/02/2020
Chromatographic Digital Immunoassay, Instrument Read H, M, W HCP, Patients, IFU None
08/18/2020 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test
08/18/2020
Microfluidic Immunofluorescence Assay, Instrument Read H, M, W HCP, Patients, IFU None None
08/26/2020 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card
08/26/2020
Lateral Flow, Visual Read H, M, W HCP, Patients, IFU None None
10/02/2020 Quidel Corporation Sofia 2 Flu + SARS Antigen FIA
10/02/2020
Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte H, M, W HCP, Patients, IFU None None
10/13/2020 Access Bio, Inc. CareStart COVID-19 Antigen test
10/08/2020
Lateral Flow, Visual Read H, M, W HCP, Patients, IFU None None

1 Authorized settings 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.


Individual EUAs for Serology Tests for SARS-CoV-2

On August 6, 2020, based on FDA's continued review of the scientific evidence available for Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum 2, including evidence from an NIH/NCI independent evaluation, FDA determined that the statutory criteria for the authorization in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, FDA determined that it is not reasonable to believe the product may be effective in detecting IgM antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

On June 16, 2020, based on FDA's continued review of the scientific evidence available for Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System for detection of IgM and IgG antibodies against SARS-CoV-2, including evidence from an NIH/NCI independent evaluation, FDA determined that the statutory criteria for issuing an EUA in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, FDA determined that it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

This table includes information about authorized SARS-CoV-2 serology/antibody assays that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.

For additional performance information about EUA authorized serology/antibody tests, please see the EUA Authorized Serology Test Performance webpage.

Date EUA Issued or Last Updated Entity Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued Attributes3 Authorized Setting(s)1 Authorization Documents2 Other Documents Other Brand Name(s)
09/18/2020 Abbott Laboratories Inc. SARS-CoV-2 IgG assay
04/26/2020
IgG, CMIA H, M HCP, Recipients, IFU-ARCHITECT, IFU-Alinityi None
06/12/2020 Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test
04/01/2020
IgM and IgG, Lateral Flow H, M HCP, Patients, IFU None None
04/24/2020 Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
04/14/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None
04/15/2020 Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test
04/15/2020
IgG, ELISA H HCP, Patients, EUA Summary None None
10/19/2020 DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG
04/24/2020
IgG, CLIA H, M HCP, Recipients, IFU None
04/24/2020 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
04/24/2020
IgG, CLIA H, M HCP, Recipients, IFU None None
07/21/2020 Bio-Rad Laboratories, Inc. Platelia SARS-CoV-2 Total Ab assay
04/29/2020
Total Antibody, ELISA H HCP, Recipients, IFU None
04/30/2020 Wadsworth Center, New York State Department of Health New York SARS-CoV Microsphere Immunoassay for Antibody Detection
04/30/2020
Total Antibody, FMIA H HCP, Recipients, EUA Summary None None
07/21/2020 Roche Diagnostics Elecsys Anti-SARS-CoV-2
05/02/2020
Total Antibody, ECLIA H, M HCP, Recipients, IFU None
05/04/2020 EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG)
05/04/2020
IgG, ELISA H HCP, Recipients, IFU None None
05/29/2020 Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
05/29/2020
IgM and IgG Lateral Flow H, M HCP, Recipients, IFU None None
05/29/2020 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 Total (COV2T)
05/29/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None None
05/29/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 Total (COV2T)
05/29/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None None
06/04/2020 Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay
06/04/2020
IgM and IgG, CLIA H HCP, Recipients, EUA Summary None None
08/31/2020 Hangzhou Biotest Biotech Co., Ltd. RightSign COVID-19 IgG/IgM Rapid Test Cassette
06/04/2020
IgM and IgG Lateral Flow H, M HCP, Recipients, IFU 
  • Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette
  • CoronaCHEK COVID-19 IgG/IgM Rapid Test Cassette
08/07/2020 Siemens Healthcare Diagnostics Inc. Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
06/08/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None
08/07/2020 Siemens Healthcare Diagnostics Inc. Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
06/08/2020
Total Antibody, CLIA H, M HCP, Recipients, IFU None
06/10/2020 InBios International, Inc. SCoV-2 Detect IgG ELISA
06/10/2020
IgG, ELISA H HCP, Recipients, IFU None None
06/15/2020 Emory Medical Laboratories SARS-CoV-2 RBD IgG test
06/15/2020
IgG, ELISA H HCP, Recipients, EUA Summary None None
10/17/2020 Biohit Healthcare (Hefei) Co. Ltd. Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
06/18/2020
IgM and IgG Lateral Flow H, M HCP, Recipients, IFU ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit
08/12/2020 Hangzhou Laihe Biotech Co., Ltd. LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
06/19/2020
IgM and IgG Lateral Flow H, M HCP, Recipients, IFU None
06/23/2020 Babson Diagnostics, Inc. Babson Diagnostics aC19G1
06/23/2020
IgG, CLIA H HCP, Recipients, EUA Summary None None
06/26/2020 Beckman Coulter, Inc. Access SARS-CoV-2 IgG
06/26/2020
IgG, CLIA H, M HCP, Recipients, IFU None None
06/30/2020 InBios International, Inc. SCoV-2 Detect IgM ELISA
06/30/2020
IgM, ELISA H HCP, Recipients, IFU None None
09/23/2020 Assure Tech. (Hangzhou Co., Ltd) Assure COVID-19 IgG/IgM Rapid Test Device
07/06/2020
IgM and IgG, Lateral Flow H, M, W HCP, Recipients, IFU None
  • Ecotest COVID-19 IgG/IgM Rapid Test Device
  • Fastep COVID-19 IgG/IgM Rapid Test Device
07/08/2020 Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit
07/08/2020
IgG, CLIA H, M HCP, Recipients, IFU None None
07/10/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab Rapid Test
07/10/2020
Total Antibody, Lateral Flow H, M HCP, Recipients, IFU None None
07/13/2020 Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
07/13/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
07/16/2020 Luminex Corporation xMAP SARS-CoV-2 Multi-Antigen IgG Assay
07/16/2020
IgG, FMIA H HCP, Recipients, IFU None None
07/17/2020 Megna Health, Inc. Rapid COVID-19 IgM/IgG Combo Test Kit
07/17/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
07/24/2020 Xiamen Biotime Biotechnology Co., Ltd. BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
07/24/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
07/24/2020 Access Bio, Inc. CareStart COVID-19 IgM/IgG
07/24/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None AQGene COVID-19 MDx RT-PCR
07/31/2020 Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 IgG (COV2G)
07/31/2020
IgG, Semi-quantitative H, M

HCP, Recipients, IFU

None None
07/31/2020 Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 IgG (COV2G)
07/31/2020
IgG, Semi-quantitative H, M HCP, Recipients, IFU None None
08/05/2020 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab ELISA
08/05/2020
Total Antibody, ELISA H HCP, Recipients, IFU None None
08/06/2020 bioMérieux SA VIDAS SARS-CoV-2 IgM
08/06/2020
IgM, ELFA H, M HCP, Recipients, IFU None None
08/06/2020 bioMérieux SA VIDAS SARS-CoV-2 IgG
08/06/2020
IgG, ELFA H, M HCP, Recipients, IFU None None
08/17/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgG and IgM Combo Test
08/17/2020
IgM and IgG, CLIA H, M HCP, Recipients, IFU None None
08/17/2020 Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit
08/17/2020
IgM, CLIA H, M HCP, Recipients, IFU None None
08/25/2020 Biocan Diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test - Letter of Authorization
08/25/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
08/31/2020 TBG Biotechnology Corp. TBG SARS-CoV-2 IgG / IgM Rapid Test Kit
08/31/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
08/31/2020 University of Arizona Genetics Core for Clinical Services COVID-19 ELISA pan-Ig Antibody Test
08/31/2020
Total Antibody, ELISA H HCP, Recipients, EUA Summary None None
09/03/2020 Sugentech, Inc. SGTi-flex COVID-19 IgG
09/03/2020
IgG, Lateral Flow H, M HCP, Recipients, IFU None None
09/09/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgM Antibody Test Kit
09/09/2020
IgM, CLIA H, M HCP, Recipients, IFU None None
09/09/2020 BioCheck, Inc. BioCheck SARS-CoV-2 IgG Antibody Test Kit
09/09/2020
IgG, CLIA H, M HCP, Recipients, IFU None None
09/14/2020 Shenzhen New Industries Biomedical Engineering Co., Ltd. MAGLUMI 2019-nCoV IgM/IgG
09/14/2020
IgM and IgG, CLIA H, M HCP, Recipients, IFU None None
09/23/2020 Jiangsu Well Biotech Co., Ltd. Orawell IgM/IgG Rapid Test
09/23/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
09/25/2020 Quotient Suisse SA MosaiQ COVID-19 Antibody Magazine
09/25/2020
Total Antibody, photometric immunoassay H HCP, Recipients, IFU None None
09/29/2020 DiaSorin, Inc. DiaSorin LIAISON SARS-CoV-2 IgM Assay
09/29/2020
IgM, Indirect CLIA H, M HCP, Recipients, IFU None None
09/29/2020 NanoEntek America, Inc. FREND COVID-19 total Ab
09/29/2020
Total Antibody, FIA H, M HCP, Recipients, IFU None None
09/29/2020 Nirmidas Biotech, Inc. Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
09/29/2020
IgM and IgG, Lateral Flow H, M HCP, Recipients, IFU None None
10/06/2020 Thermo Fisher Scientific OmniPATH COVID-19 Total Antibody ELISA Test
10/02/2020
Total Antibody, ELISA H, M HCP, Recipients, IFU None None
10/06/2020 ZEUS Scientific, Inc. ZEUS ELISA SARS-CoV-2 IgG Test System
10/06/2020
IgG, ELISA H, M HCP, Recipients, IFU None None
10/08/2020 Beckman Coulter, Inc. Access SARS-CoV-2 IgM
10/08/2020
IgM, CLIA H, M HCP, Recipients, IFU None None
10/08/2020 Genalyte, Inc. Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
10/08/2020
Total Antibody, photonic ring immunoassay H, M HCP, Recipients, IFU None None
10/09/2020 Abbott Laboratories Inc. AdviseDx SARS-CoV-2 IgM 10/09/2020 IgM, CMIA H, M

HCP, Recipients,   IFU-ARCHITECTIFU-Alinityi

None None

1 Authorized settings 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; ELFA = enzyme-linked fluorescence assay


Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2

On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by the FDA, and are confirmed by the FDA to meet the criteria set forth in the Scope of Authorization of the EUA.  To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization.

On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA.

Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.


Individual EUAs For IVDs for Management of COVID-19 Patients

This table includes information about authorized in vitro diagnostic tests that may be used in the management of patients with COVID-19 that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.

Date EUA Issued or Last Updated Entity Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued Attributes Authorized Setting(s)1 Authorization Documents2 Other Documents Other Brand Name(s)
06/02/2020 Roche Diagnostics Elecsys IL-6
06/02/2020
Immunoassay-IL-6 H, M HCP, Patients, IFU None None
10/01/2020 Beckman Coulter, Inc. Access IL-6
10/01/2020
One-step immunoenzymatic ("sandwich") assay, IL-6 H, M HCP, Patients, IFU None None

1 Authorized settings 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.

Back to Top