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  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2

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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. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests).

Molecular SARS-CoV-2 Diagnostic Tests for COVID-19 that have been granted a De Novo, 510(k) clearance or PMA

  • BioFire Respiratory Panel 2.1 (RP2.1) - On March 17, 2021, FDA granted the first marketing authorization using the De Novo review pathway for the BioFire Respiratory Panel 2.1 (RP2.1) (PDF - 630 KB). The BioFire RP2.1 is for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19. Also see the FDA news release: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process. With granting of the De Novo for the BioFire RP2.1, the FDA revoked the EUA for this device, which was initially authorized for emergency use in May 2020.
     
    The BioFire Respiratory Panel 2.1 (RP2.1)  was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria, called special controls, that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
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)
02/09/2021 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
12/01/2020 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, Pooling H HCP, Patients, IFU None
05/20/2021 Wadsworth Center, New York State Department of Public Health 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
03/29/2021 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
01/07/2021 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
01/05/2021 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
04/01/2021 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
11/13/2020 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
04/21/2021 Quidel Corporation Lyra SARS-CoV-2 Assay
03/17/2020
Real-time RT-PCR H HCP, Patients, IFU None
05/11/2021 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 (Home Collect)
None
01/22/2021 Hologic, Inc. Panther Fusion SARS-CoV-2 Assay
03/16/2020
Real-time RT-PCR, Pooling, Screening H HCP, Patients, IFU None
02/23/2021 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
03/13/2020
Real-time RT-PCR, Home Collection H HCP, Patients, IFU None
05/14/2021 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2
03/12/2020
Real-time RT-PCR, Pooling, Screening H, M, H-Pooling HCP, Patients, IFU None
02/03/2021 Mesa Biotech Inc. Accula SARS-Cov-2 Test
03/23/2020
RT and amplification H, M, W HCP, Patients, IFU None
06/17/2021 BioFire Defense, LLC BioFire COVID-19 Test
03/23/2020
RT, Nested multiplex PCR, Pooling H, M HCP, Patients, IFU None
04/01/2021 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit
03/24/2020
Real-time RT-PCR, Pooling, Screening 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
10/28/2020 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
01/22/2021 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay
03/30/2020
RT-PCR, Collection Kit, Saliva H, M HCP, Patients, IFU, IFU (Collect) 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
10/28/2020 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
05/21/2021 InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR Kit
04/07/2020
Real-time RT-PCR H HCP, Patients, IFU None
02/03/2021 DiaCarta, Inc QuantiVirus SARS-CoV-2 Test kit
04/08/2020
Real-time RT-PCR H HCP, Patients, IFU None None
04/29/2021 Becton, Dickinson and Company (BD) BD SARS-CoV-2 Reagents for BD MAX System
04/08/2020
Real-time RT-PCR, Serial Screening H, M HCP, Patients, IFU None
12/28/2020 Atila BioSystems, Inc. iAMP COVID-19 Detection Kit
04/10/2020
RT, Isothermal amplification H HCP, Patients, IFU None
12/28/2020 Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit
04/15/2020
Real-time RT-PCR H HCP, Patients, IFU 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
12/28/2020 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
04/15/2021 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
12/03/2020 Rheonix, Inc. Rheonix COVID-19 MDx Assay
04/29/2020
RT-PCR, Saliva H HCP, Patients, IFU None None
12/09/2020 Bio-Rad Laboratories, Inc Bio-Rad SARS-CoV-2 ddPCR Test
05/01/2020
RT-droplet PCR H HCP, Patients, IFU 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
04/07/2021 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
04/20/2021 OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test
05/06/2020
Real-time RT-PCR, Screening, Pooling H HCP, Patients, IFU None
01/14/2021 Sherlock BioSciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit
05/06/2020
RT-LAMP, CRISPR H HCP, Patients, IFU None None
11/06/2020 BioMérieux SA SARS-COV-2 R-GENE
05/06/2020
Real-time RT-PCR H HCP, Patients, IFU None
05/27/2021 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

  • 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
  • Wellness 4 Humanity SDNA-1000 Saliva Collection Kit
12/30/2020 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
12/23/2020 Abbott Molecular Inc. Alinity m SARS-CoV-2 assay
05/11/2020
Real-time RT-PCR, Pooling, Screening H, M HCP, Patients, IFU None
05/11/2021 Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit
05/13/2020
Real-time RT-PCR, Serial Screening H HCP, Patients, IFU None
05/24/2021 Hologic, Inc. Aptima SARS-CoV-2 assay
05/14/2020
TMA, chemiluminescent, Pooling, Screening H HCP, Patients, IFU None
01/26/2021 GeneMatrix, Inc. NeoPlex COVID-19 Detection Kit
05/14/2020
Real-time RT-PCR H HCP, Patients, IFU None
06/10/2021 Fulgent Therapeutics Fulgent COVID-19 by RT-PCR Test
05/15/2020
Real-time RT-PCR, Home Collection, Screening H HCP, Patients, EUA Summary, IFU (Home Collect) None
06/03/2021 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit
05/15/2020
Home Collection Kit N/A IFU, EUA Summary None
06/03/2021 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel
05/15/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary None None
05/25/2021 Quidel Corporation Lyra Direct SARS-CoV-2 Assay
05/18/2020
Real-time RT-PCR H HCP, Patients, IFU None
04/01/2021 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
  • AZOVA P23 At-Home COVID-19 Test Collection Kit
  • binx health (powered by P23) At-home Saliva COVID-19 Test Collection Kit for the Group Setting
02/23/2021 Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit
05/21/2020
RT-LAMP H HCP, Patients, IFU None None
12/28/2020 SolGent Co., Ltd DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
05/21/2020
Real-time RT-PCR H HCP, Patients, IFU None None
12/18/2020 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
05/19/2021 LetsGetChecked, Inc. LetsGetChecked Coronavirus (COVID-19) Test
05/28/2020
Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening H HCP, Individuals, 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
05/17/2021 Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test
06/04/2020
Real-time RT-PCR, Home Collection, Saliva, Screening H HCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic)
  • Wheeler Labs COVID-19 RT-qPCR Test
05/20/2021 Genetron Health (Beijing) Co., Ltd. Genetron SARS-CoV-2 RNA Test
06/05/2020
Real-time RT-PCR H HCP, Patients, IFU None None
04/22/2021 Euroimmun US, Inc. EURORealTime SARS-Cov-2
06/08/2020
Real-time RT-PCR H HCP, Patients, IFU None
04/22/2021 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
01/06/2021 TBG Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit
06/10/2020
Real-time RT-PCR H HCP, Patients, IFU None
03/26/2021 Cue Health Inc. Cue COVID-19 Test
06/10/2020
RT, Isothermal amplification, Screening 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
06/08/2021 Applied BioCode, Inc. BioCode SARS-CoV-2 Assay
06/15/2020
RT-PCR, Pooling H HCP, Patients, IFU None
06/17/2021 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
05/10/2021 Jiangsu Bioperfectus Technologies Co., Ltd. COVID-19 Coronavirus Real Time PCR Kit
06/18/2020
Real-time RT-PCR H HCP, Patients, IFU 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
12/28/2020 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
05/28/2021 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd. TRUPCR SARS-CoV-2 Kit
06/18/2020
Real-time RT-PCR, Saliva 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
12/28/2020 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
01/29/2021 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
02/03/2021 PlexBio Co., Ltd. IntelliPlex SARS-CoV-2 Detection Kit
06/25/2020
RT-PCR H HCP, Patients, IFU 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
05/28/2021 BioTNS Co. Ltd. COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit
06/30/2020
RT-PCR H HCP, Patients, IFU None None
05/19/2021 The Kroger Co. Kroger Health COVID-19 Test Home Collection Kit
06/30/2020
Home Collection Kit, Direct to Consumer (DTC), Screening N/A Individuals, 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
01/08/2021 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
12/28/2020 Laboratorio Clinico Toledo Laboratorio Clinico Toledo SARS-CoV-2 Assay
07/06/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
12/30/2020 Enzo Life Sciences, Inc. AMPIPROBE SARS-CoV-2 Test System
07/07/2020
Real-time RT-PCR, Pooling H HCP, Patients, IFU None None
02/05/2021 Access Bio, Inc. CareStart COVID-19 MDx RT-PCR
07/07/2020
Real-time RT-PCR H HCP, Patients, IFU
  • KarmaCare COVID-19 MDx RT-PCR
  • AQGene COVID-19 MDx RT-PCRv
12/28/2020 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
06/10/2021 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
12/28/2020 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
04/07/2021 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
11/27/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics RC SARS-CoV-2 Assay
07/15/2020
Real-time RT-PCR, Home Collection, Pooling 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
12/28/2020 DiaCarta, Inc. QuantiVirus SARS-CoV-2 Multiplex Test Kit
07/21/2020
Real-time RT-PCR H HCP, Patients, IFU None None
10/22/2020 Helix OpCo LLC Helix COVID-19 Test
07/23/2020
Real-time RT-PCR, Home Collection, Screening H HCP, Patients, EUA Summary, IFU (Home Collect) 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
04/14/2021 Color Health, Inc. Color SARS-CoV-2 RT-LAMP Diagnostic Assay
05/18/2020
RT, LAMP, Home Collection, Screening H HCP, Patients, EUA Summary 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
01/29/2021 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
11/10/2020 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
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
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 PCR Test
08/03/2020
Real-time RT-PCR, Home Collection, Saliva, Screening H HCP, Patients, EUA Summary, IFU (Home Collect) 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., Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None
01/19/2021 Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute Cleveland Clinic SARS-CoV-2 Assay
08/03/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) 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
12/28/2020 Solaris Diagnostics Solaris Multiplex SARS-CoV-2 Assay
08/10/2020
Real-time RT-PCR H HCP, Patients, EUA Summary None None
01/28/2021 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
12/30/2020 Biomeme, Inc. Biomeme SARS-CoV-2 Real-Time RT-PCR Test
08/11/2020
Real-time RT-PCR H HCP, Patient, IFU None None
12/28/2020 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
05/28/2021 Pro-Lab Diagnostics Pro-AmpRT SARS-CoV-2 Test
08/13/2020
RT, Isothermal amplification H HCP, Patient, EUA Summary None
06/03/2021 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect
08/15/2020
Real-time RT-PCR, Saliva, Home Collection, Screening 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
12/28/2020 Guardant Health, Inc. Guardant-19
08/21/2020
Sequencing H HCP, Patients, EUA Summary None None
12/09/2020 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT-PCR Test
08/21/2020
Real-time RT-PCR, Saliva H HCP, Patients, EUA Summary None
12/28/2020 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
02/26/2021 Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
08/25/2020
Real-time RT-PCR, Saliva, Home Collection H HCP, Patients, IFU, IFU (Home Collect) None
02/08/2021 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
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
04/27/2021 DxTerity Diagnostics, Inc. DxTerity SARS-CoV-2 RT PCR CE Test
08/28/2020
RT-PCR, Home Collection, Saliva H HCP, Patients, EUA Summary, IFU (Home Collect) None
12/28/2020 T2 Biosystems, Inc. T2SARS-CoV-2 Panel
08/31/2020
RT, amplification, T2 Magnetic resonance H, M 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
01/28/2021 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
06/17/2021 MobileDetect Bio Inc. MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit
09/01/2020
RT-LAMP H, M HCP, Patients, IFU None None
12/28/2020 OPTOLANE Technologies, Inc. Kaira 2019-nCoV Detection Kit
09/01/2020
Real-time RT-PCR H HCP, Patients, IFU None None
03/19/2021 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit
08/31/2020
Home Collection Kit, Screening N/A EUA Summary, IFU None None
05/24/2021 Bioeksen R&D Technologies Inc. Bio-Speedy Direct RT-qPCR SARS-CoV-2
09/02/2020
Real-time RT-PCR H HCP, Patients, IFU
  • BioeXsen SARS-CoV-2 RT PCR
06/08/2021 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
09/04/2020 BillionToOne, Inc. qSanger-COVID-19 Assay
09/04/2020
Sequencing H HCP, Patients, IFU None None
04/01/2021 Verily Life Sciences Verily COVID-19 RT-PCR Test
09/08/2020
Real-time RT-PCR, Pooling, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
10/31/2020 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
12/10/2020 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
12/28/2020 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
05/06/2021 Quadrant Biosciences Inc. Clarifi COVID-19 Test Kit
09/22/2020
Real-time RT-PCR, Saliva, Pooling 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
12/28/2020 Clear Labs, Inc. Clear Dx SARS-CoV-2 Test
09/23/2020
RT-PCR and Sequencing H HCP, Patients, IFU None None
01/27/2021 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
04/27/2021 Genetrack Biolabs, Inc. Genetrack SARS-CoV-2 Molecular Assay
09/25/2020
Real-time RT-PCR, Home Collection 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
04/02/2020 Alimetrix, Inc. Alimetrix SARS-CoV-2 RT-PCR Assay
09/30/2020
RT-PCR, Microarray Hybridization, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
03/24/2021 Tempus Labs, Inc. iC SARS-CoV2 Test
10/01/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
12/28/2020 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
04/27/2021 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
04/29/2021 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
03/29/2021 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 RNA STAR Complete
10/14/2020
RT, qSTAR amplification H HCP, Patients, IFU None
06/10/2021 Clinical Enterprise, Inc. EmpowerDX COVID-19 Home Collection Kit DTC
10/15/2020
Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary, IndividualsIFU None None
02/26/2021 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay 04/06/2020 Real-Time RT-PCR, Pooling, Screening H HCP, Patients, EUA Summary None None
05/13/2021 binx health, Inc. binx health At-Home Nasal Swab COVID-19 Sample Collection Kit
10/20/2020
Home Collection Kit N/A EUA Summary, IFU None None
05/04/2021 Agena Bioscience, Inc. MassARRAY SARS-CoV-2 Panel
10/26/2020
RT-PCR, chip array and MALDI-TOF Mass Spec. H HCP, Patients, IFU None
10/28/2020 DNA Genotek Inc. ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices
10/28/2020
Saliva Collection Device N/A EUA Summary, IFU None None
10/28/2020 DNA Genotek Inc. OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices
10/14/2020
Saliva Collection Device N/A EUA Summary, IFU None None
11/18/2020 Lucira Health, Inc. Lucira COVID-19 All-In-One Test Kit
11/17/2020
Prescription Home Testing Home, H, M, W HCP, IFU, IFU (Home Test) None None
01/22/2021 Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory Express Gene 2019-nCoV RT-PCR Diagnostic Panel
05/22/2020
Real-time RT-PCR, Collection Kit, Saliva H HCP, Patients, EUA Summary, IFU None None
11/23/2020 RapidRona, Inc. RapidRona Self-Collection Kit
11/23/2020
Home Collection Kit N/A EUA Summary, IFU (Collection) None None
06/03/2021 Gravity Diagnostics, LLC Gravity Diagnostics SARS-CoV-2 RT-PCR Assay
11/23/2020
Real-time RT-PCR, Home Collection, Saliva, Screening H HCP, Patients, EUA Summary None None
11/24/2020 Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 RT-PCR Assay
04/08/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collection) None None
04/20/2021 Cepheid Xpert Omni SARS-CoV-2
11/27/2020
Real-time RT-PCR H, M, W HCP, Patients, IFU None
12/04/2020 Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics RC COVID-19+Flu RT-PCR
12/04/2020
Real-time RT-PCR, Multi-analyte, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collection) None None
05/11/2021 Laboratory Corporation of America (LabCorp) Pixel by LabCorp COVID-19 Test Home Collection Kit
12/09/2020
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening H HCP, Individuals, EUA Summary, IFU (Home Collect) None None
05/14/2021 RCA Laboratory Services LLC dba GENETWORx GENETWORx Covid-19 Nasal Swab Test
12/15/2020
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None
12/11/2020 ResearchDx, Inc., DBA Pacific Diagnostics PacificDx Covid-19
12/11/2020
TMA, chemiluminescent, Home Collection H HCP, Patients, EUA Summary None None
05/06/2021 Hologic, Inc. Aptima SARS-CoV-2/Flu assay
12/16/2020
Real-time TMA, chemiluminescent, Multi-analyte H HCP, Patients, IFU None
12/17/2020 Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) MatMaCorp COVID-19 2SF Test
12/17/2020
RT-PCR and isothermal nucleic acid amplification H HCP, Patients, IFU None None
03/25/2021 Quidel Corporation Solana SARS-CoV-2 Assay
12/23/2020
Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) H, M HCP, Patients, IFU None
12/23/2020 Cepheid Xpert Xpress SARS-CoV-2 DoD
12/23/2020
Real-time RT-PCR, Pooling H, M, W HCP, Patients, EUA Summary None None
04/30/2021 SML GENETREE Co., Ltd. Ezplex SARS-CoV-2 G Kit
01/13/2021
Real-time RT-PCR, Pooling H HCP, Patients, IFU None
05/06/2021 Bio-Rad Laboratories, Inc. Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit
01/15/2021
Real-time RT-PCR H HCP, Patients, IFU None None
04/29/2021 Ambry Genetics Laboratory Ambry COVID-19 RT-PCR Test
01/22/2021
Real-time RT-PCR, Home Collection, Saliva H HCP, Patients, IFU (Home Collect), EUA Summary None
01/19/2021 Hospital of the University of Pennsylvania BD MAX COVID-19 ASSAY (Authorized by HHS/OASH)
01/19/2021
Real-time RT-PCR H HCP, Patients, EUA Summary None None
01/19/2021 INNO Diagnostics Reference Laboratory, Ponce Medical School PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH)
01/19/2021
Real-time RT-PCR H HCP, Patients, EUA Summary None None
02/04/2021 Clinomics USA Inc. Clinomics TrioDx RT-PCR COVID-19 Test
02/04/2021
Real-time RT-PCR H HCP, Patients, IFU None None
02/08/2021 Visby Medical, Inc. Visby Medical COVID-19 Point of Care Test
02/08/2021
RT-PCR H, M, W HCP, Patients, IFU, IFU (Collect) None None
02/11/2021 Bio-Rad Laboratories, Inc. Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit
02/11/2021
Real-time RT-PCR, Multi-analyte H HCP, Patients, IFU None None
04/29/2021 Becton, Dickinson and Company (BD) BD SARS-CoV-2/Flu for BD MAX System
02/10/2021
Real-time RT-PCR, Multi-analyte H, M HCP, Patients, IFU None
02/10/2021 Thermo Fisher Scientific TaqPath COVID-19, FluA, FluB Combo Kit
02/10/2021
Real-time RT-PCR, Multi-analyte H HCP, Patients, IFU None None
02/10/2021 Grifols Diagnostic Solutions Inc. Procleix SARS-CoV-2 Assay
02/10/2021
TMA H HCP, Patients, IFU None None
05/10/2021 Gravity Diagnostics, LLC Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits
02/13/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP, Individuals, EUA Summary None None
02/13/2021 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel DTC
02/13/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP, Individuals, EUA Summary, IFU (Home Collect) None None
02/13/2021 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit DTC
02/13/2021
Home Collection Kit, Direct to Consumer (DTC), Screening N/A Individuals, EUA Summary, IFU (Home Collect) None None
04/02/2021 University of Illinois Office of the Vice President for Economic Development and Innovation covidSHIELD
02/24/2021
Real-time RT-PCR, Saliva, Serial Screening H HCP, Patients, EUA Summary None None
05/18/2021 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay DTC
02/26/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP, Individuals, EUA Summary None None
03/05/2021 Cue Health Inc. Cue COVID-19 Test for Home and Over The Counter (OTC) Use
03/05/2021
RT, Isothermal amplification, Over the Counter (OTC) Home Testing, Screening Home, H, M, W HCP, Individuals, IFU, IFU (Home Test), FAQ None None
06/10/2021 Abbott Molecular Inc. Alinity m Resp-4-Plex
03/04/2021
Real-time RT-PCR, Multi-analyte H, M HCP, Patients, IFU None
03/03/2021 Luminex Molecular Diagnostics, Inc. NxTAG Respiratory Pathogen Panel + SARS-CoV-2
03/03/2021
RT-PCR, Multi-analyte H HCP, Patients, IFU None None
05/13/2021 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 (Version 3)
03/05/2021
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
05/26/2021 GetMyDNA GetMyDNA COVID-19 Test Home Collection Kit
03/09/2021
Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary, Individuals, IFU None None
03/19/2021 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit DTC
03/19/2021
Home Collection Kit, Direct to Consumer (DTC), Screening N/A EUA Summary, Individuals, IFU None None
03/19/2021 Color Health, Inc. Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC
03/19/2021
Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening H EUA Summary, Individuals, HCP None None
03/23/2021 Twist Bioscience Corporation SARS-CoV-2 NGS Assay
03/23/2021
Sequencing H HCP, Patients, IFU None None
04/23/2021 NeuMoDx Molecular, Inc. NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay
03/25/2021
Real-time RT-PCR, Multi-analyte H, M HCP, Patients, IFU None None
05/28/2021 STS Lab Holdco (a subsidiary of Amazon.com Services LLC) Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2
03/25/2021
Real-time RT-PCR, Home Collection, Pooling, Screening H HCP, Patients, EUA Summary, IFU (Home Collect) None None
01/19/2021 University of Louisville Infectious Diseases Laboratory SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH)
01/19/2021
Real-time RT-PCR H HCP, Patients, EUA Summary None None
04/09/2021 Lucira Health, Inc. Lucira CHECK-IT COVID-19 Test Kit
04/09/2021
RT, LAMP, Over the Counter (OTC) Home Testing, Screening Home, H, M, W HCP, IFU, IFU (Home Test) None None
04/09/2021 Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit
04/09/2021
Real-time RT-PCR H HCP, Patients, IFU None None
04/12/2021 PerkinElmer Genomics PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit
04/12/2021
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary None None
04/13/2021 Clinical Enterprise, Inc. Clinical Enterprise SARS-CoV-2 RT-PCR Assay
04/13/2021
Real-time RT-PCR, Screening H HCP, Patients, EUA Summary None None
04/13/2021 Clinical Enterprise, Inc. Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC
04/13/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP, Individuals, EUA Summary None None
05/06/2021 Yale School of Public Health, Department of Epidemiology of Microbial Diseases SalivaDirect At-Home Collection Kit
04/09/2021
Home Collection Kit, Saliva, Screening N/A EUA Summary, IFU-1, IFU-2 None
04/16/2021 Color Health, Inc. Color COVID-19 Self-Swab Collection Kit with Saline
04/14/2021
Home Collection Kit, Screening N/A EUA Summary, IFU None None
05/18/2021 LGC, Biosearch Technologies Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test
04/15/2021
Real-Time and End-Point RT-PCR H HCP, Patients, IFU None None
06/02/2021 Synergy Diagnostic Laboratory, Inc., DBA SynergyDx SynergyDx SARS-CoV-2 RNA Test DTC
04/16/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening H HCP, Individuals, EUA Summary, IFU (Home Collect)  None
06/02/2021 Synergy Diagnostic Laboratory, Inc., DBA SynergyDx SynergyDx SARS-CoV-2 RNA Test
04/16/2021
Real-time RT-PCR, Home Collection, Screening H HCP, Patients, EUA Summary, IFU (Home Collect) None
04/20/2021 Southern California Permanente Medical Group Kaiser Permanente High Throughput SARS-CoV-2 Assay
04/19/2021
Real-Time RT-PCR, Saliva, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
04/20/2021 PathogenDx, Inc. DetectX-Rv
04/20/2021
RT-PCR, DNA Microarray Hybridization H HCP, Patients, IFU None None
05/17/2021 Phosphorus Diagnostics LLC Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC
05/17/2021
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening N/A Individual, EUA Summary, IFU None None
05/17/2021 Phosphorus Diagnostics LLC Phosphorous COVID19 RT-qPCR Test DTC
05/17/2021
Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia H HCP, Individuals, EUA Summary None None
06/16/2021 Harvard University Clinical Laboratory (HUCL) Quaeris SARS-CoV-2 Assay
05/21/2021
Real-time RT-PCR, Home Collection H HCP, Patients, EUA Summary, IFU (Home Collect) None None
05/25/2021 Thermo Fisher Scientific Inc. TaqPath COVID-19 Pooling Kit
05/25/2021
Real-time RT-PCR, Pooling H HCP, Patients, IFU None None
06/08/2021 STS Lab Holdco (a subsidiary of Amazon.com Services LLC) Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2
05/28/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening H HCP, Individuals, EUA Summary, IFU, FAQ None None
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 PCR Test DTC
06/17/2021
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Saliva Screening H HCP, Individuals, EUA Summary None None
06/17/2021 WREN Laboratories LLC WREN Laboratories COVID-19 Saliva Test Collection Kit DTC
06/17/2021
Direct to Consumer (DTC), Home Collection Kit, Saliva, Screening N/A Individuals, EUA Summary, IFU None None
06/17/2021 Roche Molecular Systems cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2)
06/17/2021
Real-time RT-PCR, Screening 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.

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;

Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2

On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter. Use of tests for these indications is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.

This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week. The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media pooling or swab pooling).

Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. Tests will be added to Exhibit 1 once FDA confirms that the required documentation has been submitted. Please note that being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

Exhibit 1 of the Pooling and Serial Testing Amendment

Tests for SARS-CoV-2 that can be used for pooling as part of a serial testing program under this amendment will be added to this Exhibit.


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)
04/06/2021 Biocerna SARS-CoV-2 Test
04/28/2020
EUA Summary None
12/28/2020 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
04/03/2020 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
01/28/2021 AIT Laboratories SARS-CoV-2 Assay
04/24/2020
EUA Summary None
12/28/2020 UTMG Pathology Laboratory UTHSC/UCH SARS-CoV-2-RT-PCR Assay
05/03/2020
EUA Summary Letter Granting EUA Amendment(s) (July 22, 2020)
12/28/2020 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
01/29/2021 CSI Laboratories CSI SARS-CoV-2 RT PCR Test
06/01/2020
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
02/03/2021 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.

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