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

Sep 15, 2020 | Laboratory News, Laboratory Operations, Laboratory Pathology, Precision Medicine

This first 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 Issued or Last UpdatedEntityDiagnostic (Most Recent Letter of Authorization) and Date EUA Original IssueAttributesAuthorized Setting(s)Authorization Documents
10/13/2020Thermo Fisher Scientific, Inc.TaqPath COVID-19 Combo KitReal-time RT-PCRHHCP, Patients, IFU
3/13/2020
10/8/2020University of California, Los Angeles (UCLA)UCLA SwabSeq COVID-19 Diagnostic PlatformRT-PCR and SequencingHHCP, Patients, EUA Summary
10/6/2020
10/8/2020Spectrum Solutions LLCSDNA-1000 Saliva Collection DeviceSaliva Collection DeviceN/AEUA Summary
10/8/2020
10/7/2020GenMark Diagnostics, Inc.ePlex Respiratory Pathogen Panel 2RT-PCR and electrochemical detection, Multi-analyteH, MHCP, Patients, IFU
10/7/2020
10/6/2020Detectachem Inc.MobileDetect Bio BCC19 (MD-Bio BCC19) Test KitRT-LAMPH, MHCP, Patients, IFU
9/1/2020
10/5/2020Hologic, Inc.Aptima SARS-CoV-2 assayTMA, chemiluminescentHHCP, Patients, IFU
5/14/2020
10/5/2020SEASUN BIOMATERIALS, Inc.AQ-TOP COVID-19 Rapid Detection Kit PLUSRT-LAMPHHCP, Patients, IFU
10/5/2020
10/2/2020InBios International, IncSmart Detect SARS-CoV-2 rRT-PCR KitReal-time RT-PCRHHCP, Patients, IFU
4/7/2020
10/2/2020Cuur DiagnosticsCuur Diagnostics SARS-CoV-2 Molecular AssayReal-time RT-PCRHHCP, Patients, EUA Summary
8/26/2020
10/2/2020BioFire Diagnostics, LLCBioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)RT, Nested multiplex PCR, Multi-analyteH, M, WHCP, Patients, IFU
10/2/2020
10/1/2020Tempus Labs, Inc.iC SARS-CoV2 TestReal-time RT-PCRHHCP, Patients, EUA Summary
10/1/2020
10/1/2020UMass Memorial Medical CenterUMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx PanelReal-time RT-PCRHHCP, Patients, EUA Summary
10/1/2020
9/30/2020Aeon Global HealthAeon Global Health SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
9/30/2020
9/30/2020Alimetrix, Inc.Alimetrix SARS-CoV-2 RT-PCR AssayRT-PCR, Microarray HybridizationHHCP, Patients, EUA Summary
9/30/2020
9/29/2020CENTOGENE US, LLCCentoSure SARS-CoV-2 RT-PCR AssayReal-time RT-PCR, ScreeningHHCP, Patients, EUA Summary
9/29/2020
9/29/2020Akron Children’s HospitalAkron Children’s Hospital SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
9/29/2020
9/29/2020National Jewish HealthSARS-CoV-2 MassArray TestRT-PCR and MALDI-TOF Mass Spec.HHCP, Patients, EUA Summary
9/29/2020
9/25/2020PerkinElmer, Inc.PerkinElmer New Coronavirus Nucleic Acid Detection KitReal-time RT-PCRHHCP, Patients, IFU
3/24/2020
9/25/2020Avellino Lab USA, Inc.AvellinoCoV2 testReal-time RT-PCRHHCP, Patients, EUA Summary
3/25/2020
9/25/2020Access Genetics, LLCOraRisk COVID-19 RT-PCRReal-time RT-PCRHHCP, Patients, EUA Summary
7/17/2020
9/25/2020Genetrack Biolabs, Inc.Genetrack SARS-CoV-2 Molecular AssayReal-time RT-PCRHHCP, Patients, EUA Summary, IFU (Home Collect)
9/25/2020
9/24/2020Acupath Laboratories, Inc.Acupath COVID-19 Real-Time (RT-PCR) AssayReal-time RT-PCRHHCP, Patients, EUA Summary
6/29/2020
9/24/2020CepheidXpert Xpress SARS-CoV-2/Flu/RSVReal-time RT-PCR, Multi-analyteH, M, WHCP, Patients, IFU for Labs, IFU for Point-of-Care
9/24/2020
9/23/2020Hologic, Inc.Panther Fusion SARS-CoV-2 AssayReal-time RT-PCR, Pooling, ScreeningHHCP, Patients, IFU
3/16/2020
9/23/2020Becton, Dickinson & CompanyBD SARS-CoV-2Reagents for BD MAX SystemReal-time RT-PCRH, MHCP, Patients, IFU
4/8/2020
9/23/2020Clear Labs, Inc.Clear Dx SARS-CoV-2 TestRT-PCR and SequencingHHCP, Patients, IFU
9/23/2020
9/22/2020Becton, Dickinson & Company (BD)BioGX SARS-CoV-2 Reagents for BD MAX SystemReal-time RT-PCRH, MHCP, Patients, IFU
4/2/2020
9/22/2020ScienCell Research LaboratoriesScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection KitReal-time RT-PCRHHCP, Patients, IFU
4/3/2020
9/22/2020LabGenomics Co., Ltd.LabGun COVID-19 RT-PCR KitReal-time RT-PCRHHCP, Patients, IFU
4/29/2020
9/22/2020Color Genomics, Inc.Color Genomics SARS-CoV-2 RT-LAMP Diagnostic AssayRT, LAMP, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect), IFU (On-site Collect)
5/18/2020
9/22/2020Quadrant Biosciences Inc.Clarifi COVID-19 Test KitReal-time RT-PCR, SalivaHHCP, Patients, IFU
9/22/2020
9/22/2020Vela Operations Singapore Pte. Ltd.ViroKey SARS-CoV-2 RT-PCR Test v2.0Real-time RT-PCRHHCP, Patients, IFU
9/22/2020
9/21/2020CepheidXpert Xpress SARS-CoV-2 testReal-time RT-PCRH, M, WHCP, Patients, IFU for Labs,
3/20/2020IFU for Point-of-Care
9/21/2020Quest Diagnostics Infectious Disease, Inc.Quest SARS-CoV-2 rRT-PCRReal-time RT-PCR, Home Collection, PoolingHHCP, Patients, IFU, IFU (Home Collect)
3/17/2020
9/21/2020QIAGEN GmbHQIAstat-Dx Respiratory SARS-CoV-2 PanelReal-time RT-PCR, Multi-analyteH, MHCP, Patients, IFU
3/30/2020
9/21/2020Rheonix, Inc.Rheonix COVID-19 MDx AssayRT-PCRHHCP, Patients, IFU
4/29/2020
9/21/2020Sherlock BioSciences, Inc.Sherlock CRISPR SARS-CoV-2 KitRT-LAMP, CRISPRHHCP, Patients, IFU
5/6/2020
9/21/2020Applied DNA Sciences, Inc.Linea COVID-19 Assay KitReal-time RT-PCRHHCP, Patients, IFU
5/13/2020
9/21/2020GeneMatrix, Inc.NeoPlex COVID-19 Detection KitReal-time RT-PCRHHCP, Patients, IFU
5/14/2020
9/21/2020Assurance Scientific LaboratoriesAssurance SARS-CoV-2 PanelReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect)
5/15/2020
9/21/2020BioCore Co., Ltd.BioCore 2019-nCoV Real Time PCR KitReal-time RT-PCRHHCP, Patients, IFU
5/21/2020
9/21/2020Gravity Diagnostics, LLCGravity Diagnostics COVID-19 AssayReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary
6/1/2020
9/21/2020Euroimmun US, Inc.EURORealTime SARS-Cov-2Real-time RT-PCRHHCP, Patients, IFU
6/8/2020
9/21/2020ChromaCode Inc.HDPCR SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, IFU
6/9/2020
9/21/2020HealthQuest EsotericsHealthQuest Esoterics TaqPath SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
6/23/2020
9/21/2020Psomagen, Inc.Psoma COVID-19 RT TestReal-time RT-PCRHHCP, Patients, EUA Summary
6/30/2020
9/21/2020Centers for Disease Control and Prevention (CDC)Influenza SARS-CoV-2 (Flu SC2) Multiplex AssayReal-time RT-PCR, Multi-analyteHHCP, Patients, IFU
7/2/2020
9/21/2020KogeneBiotech Co., Ltd.PowerChek 2019-nCoV Real-time PCR KitReal-time RT-PCRHHCP, Patients, IFU
7/13/2020
9/21/2020Boston Heart DiagnosticsBoston Heart COVID-19 RT-PCR TestReal-time RT-PCRHHCP, Patients, EUA Summary
7/16/2020
9/21/2020Eli Lilly and CompanyLilly SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
7/27/2020
9/21/2020Ethos LaboratoriesEthos Laboratories SARS-CoV-2 MALDI-TOF AssayRT-PCR and MALDI-TOF Mass Spec.HHCP, Patients, EUA Summary, IFU (Home Collect)
8/3/2020
9/21/2020Exact Sciences LaboratoriesSARS-CoV-2 (N gene detection) TestReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect
5/22/2020
9/21/2020Fluidigm CorporationAdvanta Dx SARS-CoV-2 RT-PCR AssayReal-time RT-PCR, SalivaHHCP, Patients, IFU
8/25/2020
9/21/2020Patients Choice Laboratories, LLCPCL SARS-CoV-2 Real-Time RT-PCR AssayReal-time RT-PCRHHCP, Patients, EUA Summary
8/28/2020
9/21/2020KimForest Enterprise Co., Ltd.KimForest SARS-CoV-2 Detection Kit v1Real-time RT-PCRHHCP, Patients, IFU
9/21/2020
9/18/2020Laboratory Corporation of America (LabCorp)COVID-19 RT-PCR TestReal-time RT-PCR, Home Collection, Pooling, ScreeningHHCP, Patients, EUA
3/16/2020Summary, IFU (Pixel Home Collect), IFU LabCorp Home Collect
9/18/2020Bio-Rad Laboratories, IncBio-Rad SARS-CoV-2 ddPCR TestRT-droplet PCRHHCP, Patients, IFU
5/1/2020
9/18/2020Infinity BiologiX LLCInfinity BiologiX TaqPath SARS-CoV-2 AssayReal-time RT-PCR, Home Collection, SalivaHHCP, Patients, IFU (Home Collect), EUA Summary
4/10/2020
9/18/2020Roche Molecular Systems, Inc.cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat SystemReal-time RT-PCR, Multi-analyteH, M, WHCP, Patients, IFU
9/14/2020
9/18/2020GK Pharmaceuticals Contract Manufacturing OperationsGK ACCU-RIGHT SARS-CoV-2 RT-PCR KITReal-time RT-PCRHHCP, Patients, IFU
9/18/2020
9/17/2020Abbott Diagnostics Scarborough, Inc.ID NOW COVID-19RT, Isothermal amplificationH, M, WHCP, Patients, IFU
3/27/2020
9/16/2020Visby Medical, Inc.Visby Medical COVID-19RT-PCRH, MHCP, Patients, IFU
9/16/2020
9/15/2020Color Genomics, Inc.Color COVID-19 Self-Swab Collection KitHome Collection KitEUA Summary, IFU
8/31/2020
9/9/2020Kaiser Permanente Mid-Atlantic StatesKPMAS COVID-19 TestReal-time RT-PCR, Home Collection, ScreeningHHCP, Patients, EUA Summary, IFU (Home Collect)
6/13/2020
9/9/2020Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.Wantai SARS-CoV-2 RT-PCR KitReal-time RT-PCRHHCP, Patients, IFU
9/9/2020
9/8/2020Verily Life SciencesVerily COVID-19 RT-PCR TestReal-time RT-PCR, PoolingHHCP, Patients, EUA Summary
9/8/2020
9/4/2020Everlywell, Inc.Everlywell COVID-19 Test Home Collection KitHome Collection KitN/AIFU, EUA Summary
5/15/2020
9/4/2020BillionToOne, Inc.qSanger-COVID-19 AssaySequencingHHCP, Patients, IFU
9/4/2020
9/3/2020Roche Molecular Systems, Inc.cobas SARS-CoV-2 & Influenza A/BReal-time RT-PCR, Multi-analyteH, MHCP, Patients, IFU
9/3/2020
9/2/2020Bioeksen R&D Technologies Ltd.Bio-Speedy Direct RT-qPCR SARS-CoV-2Real-time RT-PCRHHCP, Patients, IFU
9/2/2020
9/1/2020SEASUN BIOMATERIALSU-TOP COVID-19 Detection KitReal-time RT-PCRHHCP, Patients, IFU
4/27/2020
9/1/2020OPTOLANE Technologies, Inc.Kaira 2019-nCoV Detection KitReal-time RT-PCRHHCP, Patients, IFU
9/1/2020
8/31/2020Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and HarvardCRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic AssayReal-time RT-PCRHHCP, Patients, EUA Summary
7/8/2020
8/31/2020T2 Biosystems, Inc.T2SARS-CoV-2 PanelRT, amplification, T2 Magnetic resonanceHHCP, Patients, IFU
8/31/2020
8/31/2020MiraDxMiraDx SARS-CoV-2 RT-PCR assayReal-time RT-PCRHHCP, Patients, EUA Summary
8/31/2020
8/31/2020Mammoth Biosciences, Inc.SARS-CoV-2 DETECTR Reagent KitRT-LAMP, CRISPRHHCP, Patients, IFU
8/31/2020
8/31/2020BayCare Laboratories, LLCBayCare SARS-CoV-2 RT PCR AssayReal-time RT-PCR, PoolingHHCP, Patients, EUA Summary
8/31/2020
8/28/2020Yale School of Public Health, Department of Epidemiology of Microbial DiseasesSalivaDirectReal-time RT-PCR, SalivaHHCP, Patients, EUA Summary
8/15/2020
8/28/2020DxTerity Diagnostics, Inc.DxTerity SARS-CoV-2 RT PCR CE TestReal-time RT-PCR, Home Collection, Screening, SalivaHHCP, Patients, EUA Summary, IFU (Home Collect)
8/28/2020
8/25/2020QDx Pathology ServicesQDX SARS-CoV-2 AssayReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect)
8/25/2020
8/24/2020Mesa Biotech Inc.Accula SARS-Cov-2 TestRT and amplificationH, M, WHCP, Patients, IFU
3/23/2020
8/24/2020Abbott Molecular Inc.Alinity m SARS-CoV-2 assayReal-time RT-PCRH, MHCP, Patients, IFU
5/11/2020
8/21/2020Quest Diagnostics Infectious Disease, Inc.Quest Diagnostics PF SARS-CoV-2 AssayReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect)
7/15/2020
8/21/2020Quest Diagnostics Infectious Disease, Inc.Quest Diagnostics RC SARS-CoV-2 AssayReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect)
7/15/2020
8/21/2020Quest Diagnostics Infectious Disease, Inc.Quest Diagnostics HA SARS-CoV-2 AssayTMA, chemiluminescent, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect)
7/15/2020
8/21/2020Guardant Health, Inc.Guardant-19SequencingHHCP, Patients, EUA Summary
8/21/2020
8/21/2020DxTerity Diagnostics, Inc.DxTerity SARS-CoV-2 RT-PCR TestReal-time RT-PCR, SalivaHHCP, Patients, EUA Summary
8/21/2020
8/21/2020Texas Department of State Health Services, Laboratory Services SectionTexas Department of State Health Services (DSHS) SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
8/21/2020
8/20/2020Illumina, Inc.Illumina COVIDSeq TestSequencingHHCP, Patients, IFU
6/9/2020
8/20/2020Cue Health Inc.Cue COVID-19 TestRT, Isothermal amplificationH, M, WHCP, Patients, IFU
6/10/2020
8/18/2020GenMark Diagnostics, Inc.ePlex SARS-CoV-2 TestRT-PCR and electrochemical detectionH, MHCP, Patients, IFU
3/19/2020
8/17/2020ZhuHai Sinochips Bioscience Co., Ltd.COVID-19 Nucleic Acid RT-PCR Test KitReal-time RT-PCRHHCP, Patients, IFU
8/17/2020
8/14/2020PrivaPath Diagnostics, Inc.LetsGetChecked Coronavirus (COVID-19) TestTMA, chemiluminescent, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect)
5/28/2020
8/13/2020Pro-Lab DiagnosticsPro-AmpRT SARS-CoV-2 TestRT, Isothermal amplificationHHCP, Patient, EUA Summary
8/13/2020
8/11/2020dba SpectronRXHymon SARS-CoV-2 Test KitReal-time RT-PCRHHCP, Patients, IFU
5/22/2020
8/11/2020Biomeme, Inc.Biomeme SARS-CoV-2 Real-Time RT-PCR TestReal-time RT-PCRHHCP, Patient, IFU
8/11/2020
8/11/2020LumiraDx UK Ltd.LumiraDx SARS-CoV-2 RNA STARRT, non-isothermal nucleic acid amplification qSTARHHCP, Patient, IFU
8/11/2020
8/10/2020Solaris DiagnosticsSolaris Multiplex SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
8/10/2020
8/10/2020Alpha Genomix LaboratoriesAlpha Genomix TaqPath SARS-CoV-2 Combo AssayReal-time RT-PCRHHCP, Patients, EUA Summary
8/10/2020
8/8/2020Trax Management Services Inc.PhoenixDx 2019-CoVReal-time RT-PCRHHCP, Patients, IFU
4/20/2020
8/8/2020Trax Management Services Inc.PhoenixDx SARS-CoV-2 MultiplexReal-time RT-PCRHHCP, Patients, IFU
7/13/2020
8/7/2020George Washington University Public Health LaboratoryGWU SARS-CoV-2 RT-PCR TestReal-time RT-PCRHHCP, Patients, EUA Summary
8/7/2020
8/6/2020Helix OpCo LLC (dba Helix)Helix COVID-19 NGS TestSequencingHHCP, Patients, EUA Summary
8/6/2020
8/5/2020Vela Operations Singapore Pte LtdViroKey SARS-CoV-2 RT-PCR TestReal-time RT-PCRHHCP, Patients, IFU
8/5/2020
8/3/2020Wren Laboratories LLCWren Laboratories COVID-19 PCR TestReal-time RT-PCRHHCP, Patients, EUA Summary
8/3/2020
8/3/2020Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine InstituteCleveland Clinic SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
8/3/2020
8/3/2020Poplar HealthcarePoplar SARS-CoV-2 TMA Pooling assayTMA, chemiluminescent, PoolingHHCP, Patients, EUA Summary
8/3/2020
8/3/2020ISPM Labs, LLC dba Capstone HealthcareGenus SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
8/3/2020
7/31/2020Xiamen Zeesan Biotech Co., Ltd.SARS-CoV-2 Test Kit (Real-time PCR)Real-time RT-PCRHHCP, Patients, IFU
7/31/2020
7/31/2020University of California San Diego HealthUCSD RC SARS-CoV-2 AssayReal-time RT-PCR, PoolingHHCP, Patients, EUA Summary
7/31/2020
7/30/2020Abbott MolecularAbbott RealTime SARS-CoV-2 assayReal-time RT-PCRHHCP, Patients, IFU
3/18/2020
7/30/2020Clinical Reference Laboratory, Inc.CRL Rapid ResponseReal-time RT-PCR, Home Collection, SalivaHHCP, Patients, EUA Summary, IFU (Home Collect)
7/30/2020
7/29/2020OPTI Medical Systems, Inc.OPTI SARS-CoV-2 RT PCR TestReal-time RT-PCRHHCP, Patients, IFU
5/6/2020
7/27/2020Seegene, Inc.Allplex 2019-nCoV AssayReal-time RT-PCRHHCP, Patients, IFU
4/21/2020
7/27/2020Sandia National LaboratoriesSNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic AssayReal-time RT-PCRHHCP, Patients, EUA Summary
7/27/2020
7/24/2020Jiangsu CoWin Biotech Co., Ltd.Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)Real-time RT-PCRHHCP, Patients, IFU
7/24/2020
7/23/2020Helix OpCo LLC (dba Helix)Helix COVID-19 TestReal-time RT-PCRHHCP, Patients, EUA Summary
7/23/2020
7/21/20203B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.TRUPCR SARS-CoV-2 KitReal-time RT-PCRHHCP, Patients, IFU
6/18/2020
7/21/2020DiaCarta, Inc.QuantiVirus SARS-CoV-2 Multiplex Test KitReal-time RT-PCRHHCP, Patients, IFU
7/21/2020
7/18/2020Atila BioSystems, Inc.iAMP COVID-19 Detection KitRT, Isothermal amplificationHHCP, Patients, IFU
4/10/2020
7/13/2020Centers for Disease Control and Prevention's (CDC)CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)Real-time RT-PCRHHCP, Patients, IFU
2/4/2020
7/13/2020Compass Laboratory Services, LLCCompass Laboratory Services SARS-CoV2 AssayReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary
7/13/2020
7/10/2020P23 Labs, LLC.P23 Labs TaqPath SARS-CoV-2 AssayReal-time RT-PCR, Home Collection, SalivaHHCP, Patients, IFU1 (Home Collect), IFU2 (Home Collect)  EUA Summary
5/21/2020
7/10/2020Boston Medical CenterBMC-CReM COVID-19 TestReal-time RT-PCRHHCP, Patients, EUA Summary
7/10/2020
7/9/2020Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)FTD SARS-CoV-2Real-time RT-PCRHHCP, Patients, IFU
5/5/2020
7/9/2020UCSF Health Clinical Laboratories, UCSF Clinical Labs at China BasinSARS-CoV-2 RNA DETECTR AssayRT-LAMPHHCP, Patients, EUA Summary
7/9/2020
7/9/2020BioSewoom, Inc.Real-Q 2019-nCoV Detection KitReal-time RT-PCRHHCP, Patients, IFU
7/9/2020
7/7/2020Enzo Life Sciences, Inc.AMPIPROBE SARS-CoV-2 Test SystemReal-time RT-PCRHHCP, Patients, IFU
7/7/2020
7/7/2020Access Bio, Inc.CareStart COVID-19 MDx RT-PCRReal-time RT-PCRHHCP, Patients, IFU
7/7/2020
7/7/2020Gene By GeneGene By Gene SARS-CoV-2 Detection TestReal-time RT-PCRHHCP, Patients, EUA Summary
7/7/2020
7/6/2020Laboratorio Clinico ToledoLaboratorio Clinico Toledo SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
7/6/2020
7/1/2020CENTOGENE US, LLCCentoFast-SARS-CoV-2 RT-PCR AssayReal-time RT-PCRHHCP, Patients, EUA Summary
7/1/2020
6/30/2020TNS Co., Ltd (Bio TNS)COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kitRT-PCRHHCP, Patients, IFU
6/30/2020
6/30/2020The Kroger Co.Kroger Health COVID-19 Test Home Collection KitHome Collection KitIFU, EUA Summary
6/30/2020
6/29/2020LifeHope LabsLifeHope 2019-nCoV Real-Time RT-PCR Diagnostic PanelReal-time RT-PCRHHCP, Patients, EUA Summary
6/29/2020
6/26/2020Inform Diagnostics, Inc.Inform Diagnostics SARS-CoV-2 RT-PCR AssayReal-time RT-PCRHHCP, Patients, EUA Summary
6/26/2020
6/25/2020Diagnostic Solutions Laboratory, LLCDSL COVID-19 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
6/25/2020
6/25/2020PreciGenome LLCFastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)RT-digital droplet PCRHHCP, Patients, IFU
6/25/2020
6/25/2020PlexBio Co., Ltd.IntelliPlex SARS-CoV-2 Detection KitRT-PCRHHCP, Patients, IFU
6/25/2020
6/24/2020Phosphorus Diagnostics LLCPhosphorus COVID-19 RT-qPCR TestReal-time RT-PCR, Home Collection, SalivaHHCP, Patients, EUA Summary, IFU (Home Collect), IFU (Clinic)
6/4/2020
6/24/2020University of Texas MD Anderson Cancer Center, Molecular Diagnostics LaboratoryMD Anderson High-throughput SARS-CoV-2 RT-PCR AssayReal-time RT-PCRHHCP, Patients, EUA Summary
6/24/2020
6/23/2020University of Alabama at Birmingham Fungal Reference LabFRL SARS CoV-2 TestReal-time RT-PCRHHCP, Patients, EUA Summary
6/23/2020
6/23/2020Gencurix, Inc.GenePro SARS-CoV-2 TestReal-time RT-PCRHHCP, Patients, IFU
6/23/2020
6/18/2020Jiangsu Bioperfectus Technologies Co., Ltd.COVID-19 Coronavirus Real Time PCR KitReal-time RT-PCRHHCP, Patients, IFU
6/18/2020
6/17/2020The Ohio State University Wexner Medical CenterOSUWMC COVID-19 RT-PCR testReal-time RT-PCRHHCP, Patients, EUA Summary
6/17/2020
6/17/2020Omnipathology Solutions Medical CorporationOmni COVID-19 Assay by RT-PCRReal-time RT-PCRHHCP, Patients, EUA Summary
6/17/2020
6/15/2020Fulgent Therapeutics, LLCFulgent COVID-19 by RT-PCR TestReal-time RT-PCR, Home CollectionHHCP, Patients, EUA Summary, IFU (Home Collect)
5/15/2020
6/15/2020Applied BioCode, Inc.BioCode SARS-CoV-2 AssayRT-PCRHHCP, Patients, IFU
6/15/2020
6/12/2020RTA Laboratories Biological Products Pharmaceutical and Machinery IndustryDiagnovital SARS-CoV-2 Real-Time PCR KitReal-time RT-PCRHHCP, Patients, IFU
6/12/2020
6/11/2020KorvaLabs Inc.Curative-Korva SARS-Cov-2 AssayReal-time RT-PCRHHCP, Patients, EUA Summary
4/16/2020
6/10/2020Tide Laboratories, LLCDTPM COVID-19 RT-PCR TestReal-time RT-PCRHHCP, Patients, EUA Summary
6/10/2020
6/10/2020TBG Biotechnology Corp.ExProbe SARS-CoV-2 Testing KitReal-time RT-PCRHHCP, Patients, IFU
6/10/2020
6/5/2020Genetron Health (Beijing) Co., Ltd.Genetron SARS-CoV-2 RNA TestReal-time RT-PCRHHCP, Patients, IFU
6/5/2020
6/4/2020DiaSorin Molecular LLCSimplexa COVID-19 Direct assayReal-time RT-PCRH, MHCP, Patients, IFU
3/19/2020
5/28/2020Zymo Research CorporationQuick SARS-CoV-2rRT-PCR KitReal-time RT-PCRHHCP, Patients, IFU
5/7/2020
5/21/2020Seasun Biomaterials, Inc.AQ-TOP COVID-19 Rapid Detection KitRT-LAMPHHCP, Patients, IFU
5/21/2020
5/21/2020SolGent Co., LtdDiaPlexQ Novel Coronavirus (2019-nCoV) Detection KitReal-time RT-PCRHHCP, Patients, IFU
5/21/2020
5/18/2020Quidel CorporationLyra Direct SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, IFU
5/18/2020
5/13/2020Roche Molecular Systems, Inc. (RMS)cobas SARS-CoV-2Real-time RT-PCRH, MHCP, Patients, IFU
3/12/2020
5/11/2020Luminex CorporationARIES SARS-CoV-2 AssayRT-PCRH, MHCP, Patients, IFU
4/3/2020
5/11/20201drop Inc.1copy COVID-19 qPCR Multi KitReal-time RT-PCRHHCP, Patients, IFU
5/11/2020
5/8/2020Gnomegen LLCGnomegen COVID-19-RT-qPCR Detection KitReal-time RT-PCRHHCP, Patients, IFU
5/8/2020
5/6/2020BioMérieux SASARS-COV-2 R-GENEReal-time RT-PCRHHCP, Patients, IFU
5/6/2020
5/4/2020Sansure BioTech Inc.Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)Real-time RT-PCRHHCP, Patients, IFU
5/4/2020
5/1/2020BioFire Diagnostics, LLCBioFire Respiratory Panel 2.1 (RP2.1)RT, Nested multiplex PCR, Multi-analyteH, MHCP, Patients, IFU
5/1/2020
4/30/2020BioFire Defense, LLCBioFire COVID-19 TestRT, Nested multiplex PCRH, MHCP, Patients, IFU
3/23/2020
4/28/2020Gnomegen LLCGnomegen COVID-19 RT-Digital PCR Detection KitReal-time RT-digital PCRHHCP, Patients, IFU
4/6/2020
4/24/2020BGI Genomics Co. LtdReal-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2Real-time RT-PCRHHCP, Patients, IFU
3/26/2020
4/23/2020SD Biosensor, Inc.STANDARD M nCoV Real-Time Detection KitReal-time RT-PCRHHCP, Patients, IFU
4/23/2020
4/23/2020NeuMoDx Molecular, Inc.NeuMoDx SARS-CoV-2 AssayRT-PCRH, MHCP, Patients, IFU
3/30/2020
4/22/2020altona Diagnostics GmbHRealStar SARS-CoV02 RT-PCR Kits U.S.Real-time RT-PCRHHCP, Patients, IFU
4/22/2020
4/18/2020OSANG HealthcareGeneFinder COVID-19 Plus RealAmp KitReal-time RT-PCRHHCP, Patients, IFU
4/18/2020
4/17/2020Fosun Pharma USA Inc.Fosun COVID-19 RT-PCR Detection KitReal-time RT-PCRHHCP, Patients, IFU
4/17/2020
4/16/2020GenoSensor, LLCGS"¢ COVID-19 RT-PCR KITReal-time RT-PCRHHCP, Patients, IFU
4/16/2020
4/15/2020Maccura Biotechnology (USA) LLCSARS-CoV-2 Fluorescent PCR KitReal-time RT-PCRHHCP, Patients, IFU
4/15/2020
4/8/2020Primerdesign Ltd.Primerdesign Ltd COVID-19 genesig Real-Time PCR assayReal-time RT-PCRHHCP, Patients, IFU
3/20/2020
4/8/2020Quidel CorporationLyra SARS-CoV-2 AssayReal-time RT-PCRHHCP, Patients, IFU
3/17/2020
4/8/2020DiaCarta, IncQuantiVirus SARS-CoV-2 Test kitReal-time RT-PCRHHCP, Patients, IFU
4/8/2020
4/3/2020Co-Diagnostics, Inc.Logix Smart Coronavirus Disease 2019 (COVID-19) KitRT-PCR, CoPrimer technologyHHCP, Patients, IFU
4/3/2020
4/1/2020Ipsum Diagnostics, LLCCOV-19 IDx assayReal-time RT-PCRHHCP, Patients, EUA Summary
4/1/2020
3/27/2020Luminex Molecular Diagnostics, Inc.NxTAG CoV Extended Panel AssayRT-PCRHHCP, Patients, IFU
3/27/2020
3/15/2020Wadsworth Center, New York State Department of Public Health's (CDC)New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic PanelReal-time RT-PCRHHCP, Patients, IFU
2/29/2020

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 UpdatedLaboratoryLetter Granting Inclusion under EUA and Original Issue DateEUA Summary
9/22/2020Diatherix Eurofins LaboratorySARS-CoV-2 PCR TestEUA Summary
4/22/2020
9/21/2020University of North Carolina Medical CenterUNC Health SARS-CoV-2 real-time RT-PCR testEUA Summary
4/10/2020
9/21/2020Pathology/Laboratory Medicine Lab of Baptist Hospital MiamiCOVID-19 RT-PCR TestEUA Summary
4/13/2020
9/21/2020Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's HospitalChildrens-Altona-SARS-CoV-2 AssayEUA Summary
4/14/2020
9/21/2020Hackensack University Medical Center (HUMC) Molecular Pathology LaboratoryCDI Enhanced COVID-19 TestEUA Summary
4/15/2020
9/21/2020CirrusDx LaboratoriesCirrusDx SARS-CoV-2 AssayEUA Summary
4/15/2020
9/14/2020Columbia University Laboratory of Personalized Genomic MedicineTRIPLEX CII-SARS-CoV-2 rRT-PCR TESTEUA Summary
5/12/2020
7/29/2020Mayo Clinic Laboratories, Rochester, MNSARS-CoV-2 Molecular Detection AssayEUA Summary
4/20/2020
7/22/2020UTMG Pathology LaboratoryUTHSC/UCH SARS-CoV-2-RT-PCR AssayEUA Summary
5/3/2020
6/12/2020Cormeum Laboratory ServicesCormeum SARS-CoV-2 AssayEUA Summary
6/12/2020
6/10/2020Warrior Diagnostics, Inc.Warrior Diagnostics SARS-CoV-2 AssayEUA Summary
6/10/2020
6/4/2020Altru Diagnostics, Inc.Altru Dx SARS-CoV-2 RT-PCR assayEUA Summary
4/30/2020
6/4/2020Yale New Haven Hospital,SARS-CoV-2 PCR testEUA Summary
Clinical Virology Laboratory3/31/2020
6/4/2020Nebraska Medicine Clinical LaboratoryNEcov19 RT-PCR AssayEUA Summary
6/4/2020
6/1/2020Aspirus Reference LaboratoryAspirus SARS-CoV rRT AssayEUA Summary
6/1/2020
6/1/2020CSI LaboratoriesCSI SARS-CoV-2 RT PCR TestEUA Summary
6/1/2020
5/22/2020Express Gene LLC (dba Molecular Diagnostics Laboratory)Express Gene 2019-nCoV RT-PCR Diagnostic PanelEUA Summary
5/22/2020
5/22/2020Avera Institute for Human GeneticsAvera Institute for Human Genetics SARS-CoV-2 AssayEUA Summary
5/22/2020
5/13/2020One Health Laboratories, LLCSARS-CoV-2 Real-Time RT-PCR-TestEUA Summary
5/13/2020
5/13/2020Cedars-Sinai Medical Center, Department of Pathology and Laboratory MedicineSARS-CoV-2-AssayEUA Summary
5/13/2020
5/7/2020Biocollections Worldwide, Inc.Biocollections Worldwide SARS-Co-V-2 AssayEUA Summary
5/7/2020
4/28/2020BiocernaSARS-CoV-2 TestEUA Summary
4/28/2020
4/27/2020Nationwide Children's HospitalSARS-CoV-2 AssayEUA Summary
4/27/2020
4/24/2020Ultimate Dx LaboratoryUDX SARS-CoV-2 Molecular AssayEUA Summary
4/24/2020
4/24/2020AIT LaboratoriesSARS-CoV-2 AssayEUA Summary
4/24/2020
4/23/2020Southwest Regional PCR Laboratory LLC. dba MicroGen DXCOVID-19 KeyEUA Summary
4/23/2020
4/14/2020Exact Sciences LaboratoriesSARS-CoV-2 TestEUA Summary
4/14/2020
4/13/2020Integrity LaboratoriesSARS-CoV-2 AssayEUA Summary
4/13/2020
4/10/2020Orig3n, Inc.Orig3n 2019 Novel Coronavirus (COVID-19) TestEUA Summary
4/10/2020
4/10/2020Specialty Diagnostic (SDI) LaboratoriesSDI SARS-CoV-2 AssayEUA Summary
4/10/2020
4/8/2020Stanford Health Care Clinical Virology LaboratoryStanford SARS-CoV-2 assayEUA Summary
4/8/2020
4/6/2020Viracor Eurofins Clinical DiagnosticsViracor SARS-CoV-2 assayEUA Summary
4/6/2020
4/3/2020Massachusetts General HospitalMGH COVID-19 qPCR assayEUA Summary
4/3/2020
4/2/2020Diagnostic Molecular Laboratory - Northwestern MedicineSARS-Cov-2 AssayEUA Summary
4/2/2020
4/2/2020Infectious Disease Diagnostics Laboratory - Children's Hospital of PhiladelphiaSARS-CoV-2 RT-PCR testEUA Summary
4/2/2020

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.

Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
Date EUA Issued or Last UpdatedEntityDiagnostic (Most Recent Letter of Authorization) and Date EUA Originally IssuedAttributesAuthorized Setting(s)1Authorization Documents2
10/13/2020Access Bio, Inc.CareStart COVID-19 Antigen testLateral Flow, Visual ReadH, M, WHCP, Patients, IFU
10/8/2020
10/2/2020Quidel CorporationSofia 2 Flu + SARS Antigen FIALateral Flow, Fluorescence, Instrument Read, Multi-AnalyteH, M, WHCP, Patients, IFU
10/2/2020
8/26/2020Abbott Diagnostics Scarborough, Inc.BinaxNOW COVID-19 Ag CardLateral Flow, Visual ReadH, M, WHCP, Patients, IFU
8/26/2020
8/18/2020LumiraDx UK Ltd.LumiraDx SARS-CoV-2 Ag TestMicrofluidic Immunofluorescence Assay, Instrument ReadH, M, WHCP, Patients, IFU
8/18/2020
7/23/2020Becton, Dickinson and Company (BD)BD Veritor System for Rapid Detection of SARS-CoV-2Chromatographic Digital Immunoassay, Instrument ReadH, M, WHCP, Patients, IFU
7/2/2020
7/17/2020Quidel CorporationSofia SARS Antigen FIALateral Flow, Fluorescence, Instrument ReadH, M, WHCP, Patients, IFU
5/8/2020

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.

Individual EUAs for Serology Tests for SARS-CoV-2

Date EUA Issued or Last UpdatedEntityDiagnostic (Most Recent Letter of Authorization) and Date EUA Originally IssuedAttributes3Authorized Setting(s)1Authorization Documents2
10/9/2020Abbott Laboratories Inc.AdviseDx SARS-CoV-2 IgM 10/09/2020IgM, CMIAH, MHCP, Recipients,   IFU-ARCHITECT,  IFU-Alinityi
10/8/2020Beckman Coulter, Inc.Access SARS-CoV-2 IgMIgM, CLIAH, MHCP, Recipients, IFU
10/8/2020
10/8/2020Genalyte, Inc.Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2Total Antibody, photonic ring immunoassayH, MHCP, Recipients, IFU
10/8/2020
10/6/2020Thermo Fisher ScientificOmniPATH COVID-19 Total Antibody ELISA TestTotal Antibody, ELISAH, MHCP, Recipients, IFU
10/2/2020
10/6/2020ZEUS Scientific, Inc.ZEUS ELISA SARS-CoV-2 IgG Test SystemIgG, ELISAH, MHCP, Recipients, IFU
10/6/2020
9/29/2020DiaSorin, Inc.DiaSorin LIAISON SARS-CoV-2 IgM AssayIgM, Indirect CLIAH, MHCP, Recipients, IFU
9/29/2020
9/29/2020NanoEntek America, Inc.FREND COVID-19 total AbTotal Antibody, FIAH, MHCP, Recipients, IFU
9/29/2020
9/29/2020Nirmidas Biotech, Inc.Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection KitIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
9/29/2020
9/25/2020Quotient Suisse SAMosaiQ COVID-19 Antibody MagazineTotal Antibody, photometric immunoassayHHCP, Recipients, IFU
9/25/2020
9/23/2020Assure Tech. (Hangzhou Co., Ltd)Assure COVID-19 IgG/IgM Rapid Test DeviceIgM and IgG, Lateral FlowH, M, WHCP, Recipients, IFU
7/6/2020
9/23/2020Jiangsu Well Biotech Co., Ltd.Orawell IgM/IgG Rapid TestIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
9/23/2020
9/18/2020Abbott Laboratories Inc.SARS-CoV-2 IgG assayIgG, CMIAH, MHCP, Recipients, IFU-ARCHITECT, IFU-Alinityi
4/26/2020
9/14/2020Shenzhen New Industries Biomedical Engineering Co., Ltd.MAGLUMI 2019-nCoV IgM/IgGIgM and IgG, CLIAH, MHCP, Recipients, IFU
9/14/2020
9/9/2020BioCheck, Inc.BioCheck SARS-CoV-2 IgM Antibody Test KitIgM, CLIAH, MHCP, Recipients, IFU
9/9/2020
9/9/2020BioCheck, Inc.BioCheck SARS-CoV-2 IgG Antibody Test KitIgG, CLIAH, MHCP, Recipients, IFU
9/9/2020
9/3/2020Sugentech, Inc.SGTi-flex COVID-19 IgGIgG, Lateral FlowH, MHCP, Recipients, IFU
9/3/2020
8/31/2020Hangzhou Biotest Biotech Co., Ltd.RightSign COVID-19 IgG/IgM Rapid Test CassetteIgM and IgG Lateral FlowH, MHCP, Recipients, IFU 
6/4/2020
8/31/2020TBG Biotechnology Corp.TBG SARS-CoV-2 IgG / IgM Rapid Test KitIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
8/31/2020
8/31/2020University of Arizona Genetics Core for Clinical ServicesCOVID-19 ELISA pan-Ig Antibody TestTotal Antibody, ELISAHHCP, Recipients, EUA Summary
8/31/2020
8/25/2020Biocan Diagnostics Inc.Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test - Letter of AuthorizationIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
8/25/2020
8/17/2020BioCheck, Inc.BioCheck SARS-CoV-2 IgG and IgM Combo TestIgM and IgG, CLIAH, MHCP, Recipients, IFU
8/17/2020
8/17/2020Diazyme Laboratories, Inc.Diazyme DZ-Lite SARS-CoV-2 IgM CLIA KitIgM, CLIAH, MHCP, Recipients, IFU
8/17/2020
8/12/2020Hangzhou Laihe Biotech Co., Ltd.LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)IgM and IgG Lateral FlowH, MHCP, Recipients, IFU
6/19/2020
8/7/2020Siemens Healthcare Diagnostics Inc.Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)Total Antibody, CLIAH, MHCP, Recipients, IFU
6/8/2020
8/7/2020Siemens Healthcare Diagnostics Inc.Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Total Antibody, CLIAH, MHCP, Recipients, IFU
6/8/2020
8/6/2020bioMérieux SAVIDAS SARS-CoV-2 IgMIgM, ELFAH, MHCP, Recipients, IFU
8/6/2020
8/6/2020bioMérieux SAVIDAS SARS-CoV-2 IgGIgG, ELFAH, MHCP, Recipients, IFU
8/6/2020
8/5/2020Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.WANTAI SARS-CoV-2 Ab ELISATotal Antibody, ELISAHHCP, Recipients, IFU
8/5/2020
8/3/2020Biohit Healthcare (Hefei) Co. Ltd.Biohit SARS-CoV-2 IgM/IgG Antibody Test KitIgM and IgG Lateral FlowH, MHCP, Recipients, IFU
6/18/2020
7/31/2020Siemens Healthcare Diagnostics Inc.Atellica IM SARS-CoV-2 IgG (COV2G)IgG, Semi-quantitativeH, MHCP, Recipients, IFU
7/31/2020
7/31/2020Siemens Healthcare Diagnostics Inc.ADVIA Centaur SARS-CoV-2 IgG (COV2G)IgG, Semi-quantitativeH, MHCP, Recipients, IFU
7/31/2020
7/24/2020Xiamen Biotime Biotechnology Co., Ltd.BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative TestIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
7/24/2020
7/24/2020Access Bio, Inc.CareStart COVID-19 IgM/IgGIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
7/24/2020
7/22/2020DiaSorin Inc.LIAISON SARS-CoV-2 S1/S2 IgGIgG, CLIAH, MHCP, Recipients, IFU
4/24/2020
7/21/2020Bio-Rad Laboratories, Inc.Platelia SARS-CoV-2 Total Ab assayTotal Antibody, ELISAHHCP, Recipients, IFU
4/29/2020
7/21/2020Roche DiagnosticsElecsys Anti-SARS-CoV-2Total Antibody, ECLIAH, MHCP, Recipients, IFU
5/2/2020
7/17/2020Megna Health, Inc.Rapid COVID-19 IgM/IgG Combo Test KitIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
7/17/2020
7/16/2020Luminex CorporationxMAP SARS-CoV-2 Multi-Antigen IgG AssayIgG, FMIAHHCP, Recipients, IFU
7/16/2020
7/13/2020Salofa OySienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test CassetteIgM and IgG, Lateral FlowH, MHCP, Recipients, IFU
7/13/2020
7/10/2020Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.WANTAI SARS-CoV-2 Ab Rapid TestTotal Antibody, Lateral FlowH, MHCP, Recipients, IFU
7/10/2020
7/8/2020Diazyme Laboratories, Inc.Diazyme DZ-Lite SARS-CoV-2 IgG CLIA KitIgG, CLIAH, MHCP, Recipients, IFU
7/8/2020
6/30/2020InBios International, Inc.SCoV-2 Detect IgM ELISAIgM, ELISAHHCP, Recipients, IFU
6/30/2020
6/26/2020Beckman Coulter, Inc.Access SARS-CoV-2 IgGIgG, CLIAH, MHCP, Recipients, IFU
6/26/2020
6/23/2020Babson Diagnostics, Inc.Babson Diagnostics aC19G1IgG, CLIAHHCP, Recipients, EUA Summary
6/23/2020
6/15/2020Emory Medical LaboratoriesSARS-CoV-2 RBD IgG testIgG, ELISAHHCP, Recipients, EUA Summary
6/15/2020
6/12/2020Cellex Inc.qSARS-CoV-2 IgG/IgM Rapid TestIgM and IgG, Lateral FlowH, MHCP, Patients, IFU
4/1/2020
6/10/2020InBios International, Inc.SCoV-2 Detect IgG ELISAIgG, ELISAHHCP, Recipients, IFU
6/10/2020
6/4/2020Vibrant America Clinical LabsVibrant COVID-19 Ab AssayIgM and IgG, CLIAHHCP, Recipients, EUA Summary
6/4/2020
5/29/2020Healgen Scientific LLCCOVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)IgM and IgG Lateral FlowH, MHCP, Recipients, IFU
5/29/2020
5/29/2020Siemens Healthcare Diagnostics Inc.Atellica IM SARS-CoV-2 Total (COV2T)Total Antibody, CLIAH, MHCP, Recipients, IFU
5/29/2020
5/29/2020Siemens Healthcare Diagnostics Inc.ADVIA Centaur SARS-CoV-2 Total (COV2T)Total Antibody, CLIAH, MHCP, Recipients, IFU
5/29/2020
5/4/2020EUROIMMUN US Inc.Anti-SARS-CoV-2 ELISA (IgG)IgG, ELISAHHCP, Recipients, IFU
5/4/2020
4/30/2020Wadsworth Center, New York State Department of HealthNew York SARS-CoV Microsphere Immunoassay for Antibody DetectionTotal Antibody, FMIAHHCP, Recipients, EUA Summary
4/30/2020
4/24/2020Ortho Clinical Diagnostics, Inc.VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent PackTotal Antibody, CLIAH, MHCP, Recipients, IFU
4/14/2020
4/24/2020Ortho-Clinical Diagnostics, Inc.VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent PackIgG, CLIAH, MHCP, Recipients, IFU
4/24/2020
4/15/2020Mount Sinai LaboratoryCOVID-19 ELISA IgG Antibody TestIgG, ELISAHHCP, Patients, EUA Summary
4/15/2020

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