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. (Source: FDA.gov)

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Date EUA IssuedManufacturerDiagnostic (Letter of Authorization)TechnologyAuthorized Setting(s)Authorization Documents: EUA Summary
9/9/2020Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.Wantai SARS-CoV-2 RT-PCR KitMolecularHNone
9/8/2020Verily Life SciencesVerily COVID-19 RT-PCR TestMolecular, PoolingHEUA Summary
9/4/2020BillionToOne, Inc.
qSanger-COVID-19 Assay
MolecularHNone
9/3/2020Roche Molecular Systems, Inc.cobas SARS-CoV-2 & Influenza A/BMolecular, Multi-analyteH, MNone
9/2/2020Bioeksen R&D Technologies Ltd.Bio-Speedy Direct RT-qPCR SARS-CoV-2MolecularHNone
9/1/2020Detectachem Inc.MobileDetect Bio BCC19 (MD-Bio BCC19) Test KitMolecularHNone
9/1/2020OPTOLANE Technologies, Inc.Kaira 2019-nCoV Detection KitMolecularHNone
8/31/2020T2 Biosystems, Inc.T2SARS-CoV-2 PanelMolecularHNone
8/31/2020MiraDxMiraDx SARS-CoV-2 RT-PCR assayMolecular, Home Collection, Screening, SalivaHEUA Summary
8/31/2020Mammoth Biosciences, Inc.SARS-CoV-2 DETECTR Reagent KitMolecularHNone
8/31/2020BayCare Laboratories, LLCBayCare SARS-CoV-2 RT PCR AssayMolecularHEUA Summary
8/31/2020Color Genomics, Inc.Color COVID-19 Test Unmonitored Collection KitHome Collection Kit
EUA Summary
8/28/2020Patients Choice Laboratories, LLCPCL SARS-CoV-2 Real-Time RT-PCR AssayMolecularHEUA Summary
8/28/2020DxTerity Diagnostics, Inc.DxTerity SARS-CoV-2 RT PCR CE TestMolecular, Home Collection, Screening, SalivaHEUA Summary
8/26/2020Cuur DiagnosticsCuur Diagnostics SARS-CoV-2 Molecular AssayMolecularHEUA Summary
8/25/2020Fluidigm CorporationAdvanta Dx SARS-CoV-2 RT-PCR AssayMolecularHNone
8/25/2020QDx Pathology ServicesQDX SARS-CoV-2 AssayMolecular, Home CollectionHEUA Summary
8/21/2020Guardant Health, Inc.Guardant-19MolecularHEUA Summary
8/21/2020DxTerity Diagnostics, Inc.DxTerity SARS-CoV-2 RT-PCR TestMolecularHEUA Summary
8/21/2020Texas Department of State Health Services, Laboratory Services SectionTexas Department of State Health Services (DSHS) SARS-CoV-2 AssayMolecularHEUA Summary
8/17/2020ZhuHai Sinochips Bioscience Co., Ltd.COVID-19 Nucleic Acid RT-PCR Test KitMolecularHNone
8/15/2020Yale School of Public Health, Department of Epidemiology of Microbial DiseasesSalivaDirectMolecularHEUA Summary
8/13/2020Pro-Lab DiagnosticsPro-AmpRT SARS-CoV-2 TestMolecularHEUA Summary
8/11/2020Biomeme, Inc.Biomeme SARS-CoV-2 Real-Time RT-PCR TestMolecularHNone
8/11/2020LumiraDx UK Ltd.LumiraDx SARS-CoV-2 RNA STARMolecularHNone
8/10/2020Solaris DiagnosticsSolaris Multiplex SARS-CoV-2 AssayMolecularHEUA Summary
8/10/2020Alpha Genomix LaboratoriesAlpha Genomix TaqPath SARS-CoV-2 Combo AssayMolecularH
EUA Summary
8/7/2020George Washington University Public Health LaboratoryGWU SARS-CoV-2 RT-PCR TestMolecularHEUA Summary
8/6/2020Helix OpCo LLC (dba Helix)Helix COVID-19 NGS TestMolecularHEUA Summary
8/5/2020Vela Operations Singapore Pte LtdViroKey SARS-CoV-2 RT-PCR TestMolecularHNone
8/3/2020Wren Laboratories LLCWren Laboratories COVID-19 PCR TestMolecularHEUA Summary
8/3/2020Ethos LaboratoriesEthos Laboratories SARS-CoV-2 MALDI-TOF AssayMolecular, Home CollectionHEUA Summary
8/3/2020Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine InstituteCleveland Clinic SARS-CoV-2 AssayMolecularHEUA Summary
8/3/2020Poplar HealthcarePoplar SARS-CoV-2 TMA Pooling assayMolecular, Sample PoolingHEUA Summary
8/3/2020ISPM Labs, LLC dba Capstone HealthcareGenus SARS-CoV-2 AssayMolecularHEUA Summary
7/31/2020Xiamen Zeesan Biotech Co., Ltd.SARS-CoV-2 Test Kit (Real-time PCR)MolecularHNone
7/31/2020University of California San Diego HealthUCSD RC SARS-CoV-2 AssayMolecular, PoolingHEUA Summary
7/30/2020Clinical Reference Laboratory, Inc.CRL Rapid ResponseMolecular, Home CollectionHEUA Summary
7/27/2020Eli Lilly and CompanyLilly SARS-CoV-2 AssayMolecularHEUA Summary
7/27/2020Sandia National LaboratoriesSNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic AssayMolecularHEUA Summary
7/24/2020Jiangsu CoWin Biotech Co., Ltd.Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)MolecularHNone
7/23/2020Helix OpCo LLC (dba Helix)Helix COVID-19 TestMolecularHEUA Summary
7/21/2020DiaCarta, Inc.QuantiVirus SARS-CoV-2 Multiplex Test KitMolecularHNone
7/17/2020Access Genetics, LLCOraRisk COVID-19 RT-PCRMolecularHEUA Summary
7/16/2020Boston Heart DiagnosticsBoston Heart COVID-19 RT-PCR TestMolecularHEUA Summary
7/15/2020Quest Diagnostics Infectious Disease, Inc.Quest Diagnostics PF SARS-CoV-2 AssayMolecular, Home CollectionHEUA Summary
7/15/2020Quest Diagnostics Infectious Disease, Inc.Quest Diagnostics RC SARS-CoV-2 AssayMolecular, Home CollectionHEUA Summary
7/15/2020Quest Diagnostics Infectious Disease, Inc.Quest Diagnostics HA SARS-CoV-2 AssayMolecular, Home CollectionHEUA Summary
7/13/2020KogeneBiotech Co., Ltd.PowerChek 2019-nCoV Real-time PCR KitMolecularHNone
7/13/2020Trax Management Services Inc.PhoenixDx SARS-CoV-2 MultiplexMolecularHNone
7/13/2020Compass Laboratory Services, LLCCompass Laboratory Services SARS-CoV2 AssayMolecular, Home CollectionHEUA Summary
7/10/2020Boston Medical CenterBMC-CReM COVID-19 TestMolecularHEUA Summary
7/9/2020UCSF Health Clinical Laboratories, UCSF Clinical Labs at China BasinSARS-CoV-2 RNA DETECTR AssayMolecularHEUA Summary
7/9/2020BioSewoom, Inc.Real-Q 2019-nCoV Detection KitMolecularHNone
7/8/2020Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and HarvardCRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic AssayMolecularHEUA Summary
7/7/2020Enzo Life Sciences, Inc.AMPIPROBE SARS-CoV-2 Test SystemMolecularHNone
7/7/2020Access Bio, Inc.CareStart COVID-19 MDx RT-PCRMolecularHNone
7/7/2020Gene By GeneGene By Gene SARS-CoV-2 Detection TestMolecularHEUA Summary
7/6/2020Laboratorio Clinico ToledoLaboratorio Clinico Toledo SARS-CoV-2 AssayMolecularHEUA Summary
7/2/2020Centers for Disease Control and Prevention (CDC)Influenza SARS-CoV-2 (Flu SC2) Multiplex AssayMolecular, Multi-analyteHNone
7/1/2020CENTOGENE US, LLCCentoFast-SARS-CoV-2 RT-PCR AssayMolecularHEUA Summary
6/30/2020Psomagen, Inc.Psoma COVID-19 RT TestMolecularHEUA Summary
6/30/2020TNS Co., Ltd (Bio TNS)COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kitMolecularHNone
6/30/2020The Kroger Co.Kroger Health COVID-19 Test Home Collection KitHome Collection KitEUA Summary
6/29/2020LifeHope LabsLifeHope 2019-nCoV Real-Time RT-PCR Diagnostic PanelMolecularHEUA Summary
6/29/2020Acupath Laboratories, Inc.Acupath COVID-19 Real-Time (RT-PCR) AssayMolecularHEUA Summary
6/26/2020Inform Diagnostics, Inc.Inform Diagnostics SARS-CoV-2 RT-PCR AssayMolecularHEUA Summary
6/25/2020Diagnostic Solutions Laboratory, LLCDSL COVID-19 AssayMolecularHEUA Summary
6/25/2020PreciGenome LLCFastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)MolecularHNone
6/25/2020PlexBio Co., Ltd.IntelliPlex SARS-CoV-2 Detection KitMolecularHNone
6/24/2020University of Texas MD Anderson Cancer Center, Molecular Diagnostics LaboratoryMD Anderson High-throughput SARS-CoV-2 RT-PCR AssayMolecularHEUA Summary
6/23/2020HealthQuest EsotericsHealthQuest Esoterics TaqPath SARS-CoV-2 AssayMolecularHEUA Summary
6/23/2020University of Alabama at Birmingham Fungal Reference LabFRL SARS CoV-2 TestMolecularHEUA Summary
6/23/2020Gencurix, Inc.GenePro SARS-CoV-2 TestMolecularHNone
6/18/2020Jiangsu Bioperfectus Technologies Co., Ltd.COVID-19 Coronavirus Real Time PCR KitMolecularHNone
6/18/20203B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.TRUPCR SARS-CoV-2 KitMolecularHNone
6/17/2020The Ohio State University Wexner Medical CenterOSUWMC COVID-19 RT-PCR testMolecularHEUA Summary
6/17/2020Omnipathology Solutions Medical CorporationOmni COVID-19 Assay by RT-PCRMolecularHEUA Summary
6/15/2020Applied BioCode, Inc.BioCode SARS-CoV-2 AssayMolecularHNone
6/13/2020Kaiser Permanente Mid-Atlantic StatesKPMAS COVID-19 TestMolecular, Home CollectionHEUA Summary
6/12/2020RTA Laboratories Biological Products Pharmaceutical and Machinery IndustryDiagnovital SARS-CoV-2 Real-Time PCR KitMolecularHNone
6/10/2020Tide Laboratories, LLCDTPM COVID-19 RT-PCR TestMolecularHEUA Summary
6/10/2020TBG Biotechnology Corp.ExProbe SARS-CoV-2 Testing KitMolecularHNone
6/10/2020Cue Health Inc.Cue COVID-19 TestMolecularH, M, WNone
6/9/2020Illumina, Inc.Illumina COVIDSeq TestMolecularHNone
6/9/2020ChromaCode Inc.HDPCR SARS-CoV-2 AssayMolecularHNone
6/8/2020Euroimmun US, Inc.EURORealTime SARS-Cov-2MolecularHNone
6/5/2020Genetron Health (Beijing) Co., Ltd.Genetron SARS-CoV-2 RNA TestMolecularHNone
6/4/2020Phosphorus Diagnostics LLCPhosphorus COVID-19 RT-qPCR TestMolecular, Home CollectionHEUA Summary,
6/1/2020Gravity Diagnostics, LLCGravity Diagnostics COVID-19 AssayMolecularHEUA Summary
5/28/2020PrivaPath Diagnostics, Inc.LetsGetChecked Coronavirus (COVID-19) TestMolecular, Home CollectionHEUA Summary
5/22/2020dba SpectronRXHymon SARS-CoV-2 Test KitMolecularHNone
5/22/2020Exact Sciences LaboratoriesSARS-CoV-2 (N gene detection) TestMolecular, Home CollectionHEUA Summary
5/21/2020P23 Labs, LLC.P23 Labs TaqPath SARS-CoV-2 AssayMolecular, Home CollectionHEUA Summary
5/21/2020Seasun Biomaterials, Inc.AQ-TOP COVID-19 Rapid Detection KitMolecularHNone
5/21/2020SolGent Co., LtdDiaPlexQ Novel Coronavirus (2019-nCoV) Detection KitMolecularHNone
5/21/2020BioCore Co., Ltd.BioCore 2019-nCoV Real Time PCR KitMolecularHNone
5/18/2020Quidel CorporationLyra Direct SARS-CoV-2 AssayMolecularHNone
5/18/2020Color Genomics, Inc.Color Genomics SARS-CoV-2 RT-LAMP Diagnostic AssayMolecular, Home CollectionHEUA Summary
5/15/2020Fulgent Therapeutics, LLCFulgent COVID-19 by RT-PCR TestMolecular, Home CollectionHEUA Summary
5/15/2020Everlywell, Inc.Everlywell COVID-19 Test Home Collection KitHome Collection KitN/AEUA Summary
5/15/2020Assurance Scientific LaboratoriesAssurance SARS-CoV-2 PanelMolecular, Home CollectionHEUA Summary
5/14/2020Hologic, Inc.Aptima SARS-CoV-2 assayMolecularHNone
5/14/2020GeneMatrix, Inc.NeoPlex COVID-19 Detection KitMolecularHNone
5/13/2020Applied DNA Sciences, Inc.Linea COVID-19 Assay KitMolecularHNone
5/11/20201drop Inc.1copy COVID-19 qPCR Multi KitMolecularHNone
5/11/2020Abbott Molecular Inc.Alinity m SARS-CoV-2 assayMolecularH, MNone
5/8/2020Gnomegen LLCGnomegen COVID-19-RT-qPCR Detection KitMolecularHNone
5/7/2020Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics – Rutgers UniversityRutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-AssayMolecular, Home CollectionHEUA Summary
5/7/2020Zymo Research CorporationQuick SARS-CoV-2rRT-PCR KitMolecularHNone
5/6/2020OPTI Medical Systems, Inc.OPTI SARS-CoV-2 RT PCR TestMolecularHNone
5/6/2020Sherlock BioSciences, Inc.Sherlock CRISPR SARS-CoV-2 KitMolecularHNone
5/6/2020BioMérieux SASARS-COV-2 R-GENEMolecularHNone
5/5/2020Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)FTD SARS-CoV-2MolecularHNone
5/4/2020Sansure BioTech Inc.Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)MolecularHNone
5/1/2020Bio-Rad Laboratories, IncBio-Rad SARS-CoV-2 ddPCR TestMolecularHNone
5/1/2020BioFire Diagnostics, LLCBioFire Respiratory Panel 2.1 (RP2.1)Molecular, Multi-analyteH, MNone
4/29/2020LabGenomics Co., Ltd.LabGun COVID-19 RT-PCR KitMolecularHNone
4/29/2020Rheonix, Inc.Rheonix COVID-19 MDx AssayMolecularHNone
4/27/2020SEASUN BIOMATERIALSU-TOP COVID-19 Detection KitMolecularHNone
4/23/2020SD Biosensor, Inc.STANDARD M nCoV Real-Time Detection KitMolecularHNone
4/22/2020altona Diagnostics GmbHRealStar SARS-CoV02 RT-PCR Kits U.S.MolecularHNone
4/21/2020Seegene, Inc.Allplex 2019-nCoV AssayMolecularHNone
4/20/2020Trax Management Services Inc.PhoenixDx 2019-CoVMolecularHNone
4/18/2020OSANG HealthcareGeneFinder COVID-19 Plus RealAmp KitMolecularHNone
4/17/2020Fosun Pharma USA Inc.Fosun COVID-19 RT-PCR Detection KitMolecularHNone
4/16/2020KorvaLabs Inc.Curative-Korva SARS-Cov-2 AssayMolecularHEUA Summary
4/16/2020GenoSensor, LLCGSӢ COVID-19 RT-PCR KITMolecularHNone
4/15/2020Maccura Biotechnology (USA) LLCSARS-CoV-2 Fluorescent PCR KitMolecularHNone
4/10/2020Atila BioSystems, Inc.iAMP COVID-19 Detection KitMolecularHNone
4/8/2020DiaCarta, IncQuantiVirus SARS-CoV-2 Test kitMolecularHNone
4/8/2020Becton, Dickinson & CompanyBD SARS-CoV-2Reagents for BD MAX SystemMolecularH, MNone
4/7/2020InBios International, IncSmart Detect SARS-CoV-2 rRT-PCR KitMolecularHNone
4/6/2020Gnomegen LLCGnomegen COVID-19 RT-Digital PCR Detection KitMolecularHNone
4/3/2020Co-Diagnostics, Inc.Logix Smart Coronavirus Disease 2019 (COVID-19) KitMolecularHNone
4/3/2020ScienCell Research LaboratoriesScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection KitMolecularHNone
4/3/2020Luminex CorporationARIES SARS-CoV-2 AssayMolecularH, MNone
4/2/2020Becton, Dickinson & Company (BD)BioGX SARS-CoV-2 Reagents for BD MAX SystemMolecularH, MNone
4/1/2020Ipsum Diagnostics, LLCCOV-19 IDx assayMolecularHEUA Summary
3/30/2020QIAGEN GmbHQIAstat-Dx Respiratory SARS-CoV-2 PanelMolecular, Multi-analyteH, MNone
3/30/2020NeuMoDx Molecular, Inc.NeuMoDx SARS-CoV-2 AssayMolecularH, MNone
3/27/2020Luminex Molecular Diagnostics, Inc.NxTAG CoV Extended Panel AssayMolecularHNone
3/27/2020Abbott Diagnostics Scarborough, Inc.ID NOW COVID-19MolecularH, M, WNone
3/26/2020BGI Genomics Co. LtdReal-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2MolecularHNone
3/25/2020Avellino Lab USA, Inc.AvellinoCoV2 testMolecularHEUA Summary
3/24/2020PerkinElmer, Inc.PerkinElmer New Coronavirus Nucleic Acid Detection KitMolecularHNone
3/23/2020Mesa Biotech Inc.Accula SARS-Cov-2 TestMolecularH, M, WNone
3/23/2020BioFire Defense, LLCBioFire COVID-19 TestMolecularH, MNone
3/20/2020CepheidXpert Xpress SARS-CoV-2 testMolecularH, M, W
3/20/2020Primerdesign Ltd.Primerdesign Ltd COVID-19 genesig Real-Time PCR assayMolecularHNone
3/19/2020GenMark Diagnostics, Inc.ePlex SARS-CoV-2 TestMolecularH, MNone
3/19/2020DiaSorin Molecular LLCSimplexa COVID-19 Direct assayMolecularH, MNone
3/18/2020Abbott MolecularAbbott RealTime SARS-CoV-2 assayMolecularHNone
3/17/2020Quest Diagnostics Infectious Disease, Inc.Quest SARS-CoV-2 rRT-PCRMolecular, Home Collection, Sample PoolingHNone
3/17/2020Quidel CorporationLyra SARS-CoV-2 AssayMolecularHNone
3/16/2020Laboratory Corporation of America (LabCorp)COVID-19 RT-PCR TestMolecular, Home Collection, Pooling, ScreeningHEUA Summary
3/16/2020Hologic, Inc.Panther Fusion SARS-CoV-2 AssayMolecularHNone
3/13/2020Thermo Fisher Scientific, Inc.TaqPath COVID-19 Combo KitMolecularHNone
3/12/2020Roche Molecular Systems, Inc. (RMS)cobas SARS-CoV-2MolecularH, MNone
2/29/2020Wadsworth Center, New York State Department of Public Health’s (CDC)New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic PanelMolecularHNone
2/4/2020Centers for Disease Control and Prevention’s (CDC)CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)MolecularHNone