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Coronavirus Test Tracker: Commercially Available COVID-19 Diagnostic Tests

As labs and diagnostic developers race to meet demand for assays to detect the SARS-CoV-2 coronavirus, 360Dx is updating this tracker on a regular basis in order to provide readers with up-to-date and accurate information on the regulatory status of these tests in the US, European, and Asian markets

The tracker includes only those tests that are available for diagnostic and clinical use. Links to primary regulatory decisions are provided where available. We rely on information provided by manufacturers and regulatory authorities. If you're a test manufacturer or provider and believe your test should be on this tracker, please email us at [email protected].

Last updated: Nov. 23, 2020


EUA: Emergency Use Authorization

EUA submission pending: Test manufacturers have indicated that they have submitted an EUA application. FDA requires labs and commercial manufacturers to submit an EUA request within 10 days (serological test) or 15 days (molecular test) of completing test validation.

Under CDC's EUA: these manufacturers are covered under the EUA granted to the US Centers for Disease Control and Prevention

*See US FDA Revised Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency

Test NameUS Regulatory Status*EU Regulatory StatusAsia Regulatory StatusTechnology

1copy COVID-19 qPCR Multi Kit

EUA 5/11/2020   PCR
3B Blackbio Biotech India (Kilpest India subsidiary)


EUA 6/18/2020  PCR
3D Medicines

SARS-CoV-2 and Influenza A & B RT-qPCR Detection Kit

 CE mark 3/2020 PCR
Abacus Diagnostica

GenomEra SARS-CoV-2 Assay

 CE mark 7/2020 PCR

AdviseDx SARS-CoV-2 IgM

EUA 10/9/2020  Serological

BinaxNOW COVID-19 Ag Card

EUA 8/26/2020

AbbottSARS-CoV-2 IgG test

EUA 4/26/2020, amended 5/9/2020

AbbottID Now COVID-19EUA 3/27/2020  isothermal amplification
AbbottAbbott RealTime SARS-CoV-2 EUA testEUA 3/18/2020  PCR

Access Bio

CareStart COVID-19 Antigen test

EUA 10/8/2020  Antigen

Access Bio

CareStart COVID-19 IgM/IgG

EUA 7/24/2020  Serological

Access Bio

CareStart COVID-19 MDx RT-PCR

EUA 7/7/2020  PCR

Access Genetics


EUA 7/17/2020  PCR

Acupath Laboratories

Acupath COVID-19 Real-Time (RT-PCR) Assay

EUA 6/29/2020  PCR

ADS Biotec

SARS-CoV-2 IgM/IgG Antibody Test Kit

EUA 6/18/2020CE mark 3/2020 Serological

Advanced Biological Laboratories

UltraGene Combo2Screen SARS-CoV-2 assay

 CE mark 5/2020 PCR

Aeon Global Health

Aeon Global Health SARS-CoV-2 Assay

EUA 9/30/2020  PCR 

AEP Alliance (Antaimmu Biomed, EirGenix, Panion & BF Biotech)

Vstrip COVID-19 Antigen Rapid Test


Taiwan EUA 8/2020

Indian Council of Medical Research validation 9/2020


Agena Bioscience

MassArray SARS-CoV-2 Panel

EUA 10/26/2020CE mark 9/2020 Mass spectrometry

AIT Laboratories

SARS-CoV-2 Assay

EUA 4/24/2020  PCR
Akron Children's Hospital

Akron Children's Hospital SARS-CoV-2 Assay

EUA 9/29/2020  PCR
Akston Biosciences


EUA submission pending  Serological

Alimetrix SARS-CoV-2 RT-PCR Assay

EUA 9/30/2020  PCR, microarray
ALPCO (American Laboratory Products Company)

ALPCO SARS-CoV-2 IgG Chemiluminescence ELISA

EUA submission pending  Serological
ALPCO (American Laboratory Products Company)

ALPCO SARS-CoV-2 IgM Chemiluminescence ELISA

EUA submission pending  Serological
ALPCO (American Laboratory Products Company)


EUA submission pending  Serological
ALPCO (American Laboratory Products Company)


EUA submission pending  Serological
Alpha Genomix Laboratories

Alpha Genomix TaqPath SARS-CoV-2 Combo Assay

EUA 8/10/2020  PCR
Altru Diagnostics

Altru Dx SARS-CoV-2 RT-PCR assay

EUA 4/30/2020   PCR
Altona Diagnostics

RealStar SARS-CoV-2 RT-PCR Kits (1.0 and U.S versions)

EUA 4/22/2020CE mark 4/2020 PCR

A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit

EUA submission pendingCE mark 7/2020

Korea Ministry of Food and Drug Safety EUA 7/2020

Philippines FDA 9/2020

Anatolia GeneworksBosphore Novel Coronavirus (2019-nCoV) Detection Kit CE mark 2/2020 PCR

AniCon Labor

Kylt SARS-CoV-2Complete RTU

 CE mark 6/2020 PCR

Applied BioCode

BioCode SARS-CoV-2 Assay

EUA 6/15/2020  PCR

Applied DNA Sciences

Linea COVID-19 RT-PCR test

EUA 5/13/2020  PCR
ArcDia InternationalMariPOC COVID-19 test CE mark 5/2020 Antigen

Aspirus Reference Laboratory

Aspirus SARS-CoV rRT-PCR Assay

EUA 6/1/2020  PCR
Assurance Scientific Laboratories

Assurance SARS-CoV-2 Panel

EUA 5/15/2020  PCR

Assure Tech (Hangzhou Co.)

Assure COVID-19 IgG/IgM Rapid Test Device

EUA 7/6/2020  Serological

A*STAR,Tan Tock Seng Hospital of Singapore

A*STAR Fortitude 2.0

  Singapore Health Sciences Authority provisional authorizationPCR

Atila BioSystems

iAMP COVID-19 Detection Kit

EUA 4/10/2020  Isothermal amplification

AusDiagnostics SARS-CoV-2, influenza, RSV panel

 CE mark 3/2020 PCR
Autobio DiagnosticsAnti-SARS-CoV-2 Rapid Test

EUA 4/24/2020

EUA revoked 8/6/2020

CE mark Serological
Avellino LabAvellino SARS-CoV-2/COVID-19 (AvellinoCoV2)EUA 3/25/2020  PCR

Avera Institute for Human Genetics

Avera Institute for Human Genetics SARS-CoV-2 Assay

EUA 5/22/2020   PCR

Babson Diagnostics

Babson Diagnostics aC19G1

EUA 6/23/2020  Serological

BAG Diagnostics

Viro-Q SARS-CoV-2 kit

 CE mark 4/2020 PCR

Bako Diagnostics

BakoDx SARS-CoV-2 RNA test

EUA submission pending  PCR

Baptist Hospital Miami Pathology/Laboratory Medicine Lab


EUA 4/13/2020  PCR

BayCare Laboratories

BayCare SARS-CoV-2 RT PCR Assay 

EUA 8/31/2020  PCR

Beckman Coulter

Access SARS-CoV-2 IgM

EUA 10/8/2020CE mark 11/2020 Serological

Beckman Coulter

Access SARS-CoV-2 IgG

EUA 6/26/2020CE mark 6/2020 Serological

Becton Dickinson

BD Veritor System for Rapid Detection of SARS-CoV-2

EUA 7/2/2020  Antigen

Becton Dickinson

BD SARS-CoV-2 Reagents for BD MAX System

EUA 4/8/2020  PCR

Becton Dickinson, BioGx

BioGX SARS-CoV-2 Reagents for the BD MAX System

EUA 4/2/2020  PCR

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 RT-PCR Kit

EUA 9/9/2020  PCR

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 Ab ELISAEUA 8/5/2020   Serological

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 Ab Rapid Test

EUA 7/10/2020  Serological
Beroni GroupSARS-CoV-2 IgG/IgM Antibody Detection Kit CE mark 4/2020 Serological
BGI (BGI PathoGenesis Pharmaceutical Technology)SARS-CoV-2 and Influenza A/B RT-PCR Kits CE mark 9/2020 PCR
BGIReal-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoVEUA 3/26/2020CE mark 3/2/2020China NMPA 1/2020PCR


qSanger-COVID-19 Assay

EUA 9/4/2020  Sequencing

Binx Health

Binx Health At-Home Nasal Swab COVID-19 Sample Collection Kit

EUA 10/20/2020  Collection kit

Biocan Diagnostics

Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

EUA 8/25/2020  Serological


Idylla SARS-CoV-2 TestEUA submission pendingCE mark 11/2020 PCR


SARS-CoV-2 TestEUA 4/28/2020  PCR

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgM Antibody Test KitEUA 9/9/2020  Serological

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgG Antibody Test Kit

EUA 9/9/2020  Serological

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgM and IgG Combo TestEUA 8/17/2020  Serological

Biocollections Worldwide

Biocollections Worldwide SARS-Co-V-2 AssayEUA 5/7/2020  PCR


BioCore 20019-nCoV Real Time PCR Kit

EUA 5/21/2020  PCR



SARS-CoV-2 Droplet Digital PCR (ddPCR) test

EUA submission pending  PCR

Bioeksen R&D Technologies

Bio-Speedy Direct RT-qPCR SARS-CoV-2

EUA 9/2/2020  PCR


Xfree COVID-19 Direct RT-PCR test

EUA submission pending  PCR

Biohit Healthcare (Hefei)

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

EUA 6/18/2020  Serological


COVID-19 IgM-IgG Rapid Test

 CE mark 3/2020 Serological

Biomeme SARS-CoV-2 Real-Time RT-PCR Test

EUA 8/11/2020   PCR

COVID-19 IgG/IgM Rapid Test

 CE mark 5/2020 Serological

Vidas anti-SARS-CoV-2 IgM test

EUA 8/6/2020 CE mark 5/2020 Serological
BioMérieuxVidas anti-SARS-CoV-2 IgG testEUA 8/6/2020 CE mark 5/2020 Serological


EUA 5/6/2020CE mark 4/10/2020 PCR

BioMérieux/BioFire Defense

BioFire COVID-19 test

EUA 3/23/2020  PCR
BioMérieux/BioFire Diagnostics

BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)

EUA 10/2/2020  PCR
BioMérieux/BioFire Diagnostics

BioFire Respiratory Panel 2.1 (RP2.1) (EUA)

BioFire Respiratory Panel 2.1 plus (CE mark)

EUA 5/1/2020 CE mark 7/2020 PCR

AccuPower RV1 Multiplex Kit

 CE mark 11/2020 PCR

AccuPower RV1 Real-Time RT-PCR Kit

 CE mark 11/2020 PCR

AccuPower COVID-19 Real-Time RT-PCR Kit, AccuPower SARS-CoV-2 Real-Time RT-PCR Kit

 CE mark PCR
Biopanda Reagents

COVID-19 Rapid Antibody Test

 CE mark 3/2020 Serological
Bio-Rad Laboratories

Bio-Rad SARS-CoV-2 ddPCR Test

EUA 5/1/2020  PCR
Bio-Rad Laboratories

Platelia SARS-CoV-2 Total Ab assay

EUA 4/29/2020 CE mark 4/2020 Serological
BioReference Laboratories

Novel Coronavirus COVID-19

EUA submission pending  PCR
BioSewoonReal-Q 2019-nCoV Detection KitEUA 7/9/2020  PCR
Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL)Childrens-Altona-SARS-CoV-2 assayEUA 4/14/2020  PCR

Boston Heart Diagnostics

Boston Heart COVID-19 RT-PCR Test

EUA 7/16/2020  PCR

Boston Medical Center


EUA 7/10/2020   PCR

Broad Institute Clinical Research Sequencing Platform (CRSP)

CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay

EUA 7/8/2020, reissued 10/23/2020  PCR


FluoroType SARS-CoV-2 plus

 CE mark 5/5/2020 PCR

Capstone Healthcare

Genus SARS-CoV-2 Assay

EUA 8/3/2020  PCR

Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine


EUA 5/13/2020  PCR

qSARS-CoV-2 IgG/IgM Rapid Test

EUA 4/1/2020  Serological

Sampinute COVID-19 Antigen MIA

EUA 10/23/2020  Antigen
Centers for Disease Control and PreventionCDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC)EUA 2/4/2020, amended 3/15/2020  PCR
Centers for Disease Control and Prevention

Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay

EUA 7/2/2020  PCR

CentoSure SARS-CoV-2 RT-PCR Assay

EUA 9/29/2020  PCR

SARS-CoV-2 RT-PCR test

EUA 7/1/2020  PCR

Xpert Xpress SARS-CoV-2/Flu/RSV test

EUA 9/24/2020  PCR

Xpert Xpress SARS-CoV-2 test

EUA 3/20/2020  PCR
CerTest BioTec

Viasure SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit

 CE mark 10/2020 on BD Max system PCR
CerTest BioTecViaSure SARS-CoV-2 Real Time PCR Detection Kit CE mark 3/2020 on BD Max system PCR
Chembio Diagnostics
DDP COVID-19 IgM/IgG System

EUA 4/14/2020

EUA revoked 6/16/2020


Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory

SARS-CoV-2 RT-PCR testEUA 4/2/2020  PCR


HDPCR SARS-CoV-2 real-time PCR assayEUA 6/9/2020  PCR

CirrusDx Laboratories

CirrusDx SARS-CoV-2 Assay

EUA 4/15/2020   PCR
Clear Labs

Clear Dx SARS-CoV-2

EUA 9/23/2020  Sequencing
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute

Cleveland Clinic SARS-CoV- Assay

EUA 8/3/2020  PCR
Clinical Enterprise

EmpowerDX At-Home COVID-19 PCR Test Kit

EUA 10/15/2020   Collection kit
Clinical Reference Laboratory

CRL Rapid Response

EUA 7/30/2020  Molecular

Logix Smart SARS-CoV-2 Multi-Gene Test

 CE mark 11/2020 PCR

Logix Smart ABC Assay

 CE mark 11/2020 PCR

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

EUA 4/3/2020CE mark 2/2020 PCR


Color COVID-19 Self-Swab Collection Kit

EUA 8/31/2020  Collection kit


Color SARS-CoV-2 LAMP Diagnostic Assay

EUA 5/18/2020, reissued 11/2/2020  Isothermal amplification

Columbia University Laboratory of Personalized Genomic Medicine

Triplex CII-CoV-1 rRT-PCR Test

EUA 5/12/2020  PCR
Compass Laboratory ServicesCompass Laboratory Services SARS-CoV2 AssayEUA 7/13/2020  PCR, Home Collection
Cormeum Laboratory ServicesCormeum SARS-CoV-2 AssayEUA 6/12/2020  PCR
CoWin Biotech

Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

EUA 7/24/2020  PCR
Credo Diagnostics Biomedical

VitaPCR Influenza A&B/SARS-CoV-2 assay

 CE mark 10/2020 PCR
Credo Diagnostics BiomedicalVitaPCR SARS-CoV2 Assay CE mark 3/2020Singapore Health Sciences Authority provisional authorization

CSI Laboratories


EUA 6/1/2020  PCR
CTK Biotech

OnSite COVID-19 IgG/IgM Rapid Test

EUA submission pendingCE mark Q1/2020 Serological
CTK Biotech

Aridia COVID-19 PCR Test

 CE mark Q2/2020  
Cue Health

Cue COVID-19 Test

EUA 6/10/2020  PCR

Cuur Diagnostics

Cuur Diagnostics SARS-CoV-2 Molecular Assay

EUA 8/26/2020   PCR 
Darwin Biosciences


EUA submission pending  PCR
Dba SpectronRx

Hymon SARS-CoV-2 Test Kit

EUA 5/22/2020  PCR


MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit

EUA 9/1/2020  isothermal amplification

QuantiVirus SARS-CoV-2 Multiplex Test Kit

EUA 7/21/2020  PCR

QuantiVirus SARS-CoV-2 test kit

EUA 4/8/2020CE mark 3/2020 PCR
Diagnostics Development HubFortitude Kit 2.0E  Singapore Health Sciences Authority provisional authorization 2/2020PCR
Diagnostic Solutions LaboratoryDSL COVID-19 AssayEUA 6/25/2020  PCR

Liaison SARS-CoV-2 Ag

 CE mark 10/2020 Antigen

Diasorin Liaison SARS-CoV-2 IgM Assay

EUA 9/29/2020  Serological 

Liaison SARS-CoV-2 S1/S2 IgG

EUA 4/24/2020  CE mark 4/2020 Serological
DiaSorin Molecular

Simplexa COVID-19 Direct

EUA 3/19/2020 CE mark 4/2020 PCR
Diatherix Eurofins LaboratorySARS-CoV-2 PCR TestEUA 4/22/2020  PCR
Diazyme Laboratories

Diazyme DZ-Lite SARS-CoV-2 IgG CLIA kit

EUA 7/8/2020  Serological
Diazyme Laboratories 

Diazyme DZ-Lite SARS-CoV-2 IgM

EUA 8/17/2020  Serological

DNA Genotek/OraSure Technologies

ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100saliva collection devices

EUA 10/28/2020   Collection device

DNA Genotek/OraSure Technologies

Omnigene·Orall OM-505 and OME-505 (Omnigene·Oral) saliva collection devices

EUA 10/14/2020, reissued 10/28/2020  Collection device

DNA-Technology Research & Production

SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit

 CE mark 4/2020 PCR

DxTerity Diagnostics


DxTerity SARS-CoV-2 RT PCR CE Test

EUA 8/28/2020   PCR 

DxTerity Diagnostics

DxTerity SARS-CoV-2 RT-PCR Test

EUA 8/21/2020  PCR
Eli Lilly

Lilly SARS-CoV-2 Assay

EUA 7/27/2020  PCR

SARS-CoV-2 Plus ELITe MGB Assay

EUA submission pending  PCR
Emory Medical Laboratories

SARS-CoV-2 RBD IgG test

EUA 6/15/2020  Serological
Empirical Bioscience

QuantiTase, QuantiTase Plus One Step RT-qPCR Kits

EUA submission pending  PCR
Ender Diagnostics

Ender Lab

 CE mark 6/2020 PCR
Ender Diagnostics

Ender Mass

 CE mark 8/2020 Isothermal amplification
Enzo Biochem

Genflex Molecular Diagnostic Modular System (for SARS-CoV-2 Detection)

EUA submission pending  PCR
Enzo Biochem

SARS-CoV-2 IgG ELISA assay kit

EUA submission pending  Serological
Enzo Biochem/Enzo Life Sciences

Ampiprobe SARS-CoV-2 Test System

EUA 7/7/2020  PCR
Erba Mannheim


 CE mark 4/2020 Serological
Erba Mannheim


 CE mark 4/2020 Serological
Ethos Laboratories

Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay

EUA 8/3/2020  Mass spectrometry
Eurofins Ingenasa

Ingezim COVID 19 DR

 CE mark 6/2020 Serological


EUA 5/4/2020  Serological

EuroRealTime SARS-CoV-2

EUA 6/8/2020CE mark 3/2020 PCR


 CE mark 3/2020 Serological


Everlywell COVID-19 Test Home Collection Kit

EUA 5/15/2020  Home collection kit

Exact Sciences

Exact Sciences SARS-CoV-2 (N gene detection) Test

EUA 5/22/2020  PCR

Exact Sciences

SARS-CoV-2 Test

EUA 4/14/2020  PCR

Express Gene (dba Molecular Diagnostics Laboratory)

Express Gene 2019-nCoV RT-PCR Diagnostic Panel

EUA 5/22/2020   PCR


Advanta Dx SARS-CoV-2 RT-PCR Assay

EUA 8/25/2020  PCR

Fosun Pharma USA

Fosun COVID-19 RT-PCR Detection Kit

EUA 4/17/2020  PCR
Fulgent Genetics/Fulgent TherapeuticsFulgent COVID-19 by RT-PCR TestEUA 5/15/2020  PCR
Fulgent Genetics/MedScan LaboratoryCOVID-19EUA submission pending  Sequencing

Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2

EUA 10/8/2020  Serological

GenePro SARS-CoV-2 Test

EUA 6/23/2020  PCR
Gene By Gene

Gene By Gene SARS-CoV-2 Detection Test

EUA 7/7/2020  PCR

Genedrive 96 SARS-CoV-2 Kit

EUA submissiong pendingCE mark 5/2020 PCR

NeoPlex COVID-19 Detection Kit

EUA 5/14/2020  PCR
General Biologicals


 CE mark 8/2020 Serological
General Biologicals

GB SARS-CoV-2 Real-Time RT-PCR

 CE mark 4/2020Taiwan FDA approval; India Central Drugs Standard Control Organisation approvalPCR

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

 CE mark 9/2020 Antigen
GeneStore France 

Detection Expert SARS-Cov-2 RT-PCR Test

 CE mark 4/2020 PCR
Genetic Signatures

EasyScreen SARS-CoV-2 detection kit

 CE mark 3/2020 PCR
Genetrack Biolabs

Genetrack SARS-CoV-2 Molecular Assay

EUA 9/25/2020  PCR

Genetron SARS-CoV-2 RNA Test

EUA 6/5/2020CE mark 4/2020 PCR
GenMark Diagnostics

ePlex Respiratory Pathogen Panel 2 (RP2)

EUA 10/8/2020CE mark 9/2020 PCR
GenMark Diagnostics

ePlex SARS-CoV-2 Test (discontinued)

EUA 3/19/2020  PCR
GenMark DiagnosticseSensor SARS-CoV-2 testEUA submission pending  PCR
Genomica/PharmMar Group2 kits: qCOVID-19, CLART COVID-19 CE mark 3/2020 PCR

GenScript Biotech

cPass SARS-CoV-2 Neutralization Antibody Detection Kit

EUA 11/6/2020CE mark 5/2020 Serological



EUA 4/16/2020   PCR

George Washington University Public Healt Laboratory


EUA 8/7/2020  PCR

GK Pharmaceuticals Contract Manufacturing Operations

GK Accu-Right SARS-CoV-2 RT-PCR Kit

EUA 9/18/2020  PCR

Gnome Diagnostics

GnomeDX RT-PCR COVID-19 Test

EUA submission pending  PCR


Gnomegen COVID-19-RT-qPCR Detection Kit

EUA 5/8/2020  PCR


Gnomegen COVID-19 RT-Digital PCR Detection Kit

EUA 4/6/2020  PCR
Gold Standard Diagnostics/Eurofins Technologies

GSD NovaPrime SARS-CoV-2 (COVID-19) Real-Time PCR test

 CE mark 5/2020 PCR
Gold Standard Diagnostics/Eurofins Technologies
NovaLisa SARS-CoV-2 (US: GSD SARS-CoV-2) IgG, IgM, IgA assays
CE mark 4/2020 Serological

Gravity Diagnostics

Gravity Diagnostics COVID-19 Assay   EUA 6/1/2020  PCR


Procleix SARS-CoV-2 Assay

 CE mark 5/2020 Isothermal amplification

Guardant Health


EUA 8/21/2020  Sequencing

Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory

CDI Enhanced COVID-19 Test

EUA 4/15/2020  PCR
Hai Kang Life

C/Tech SARS-CoV-2 ERT-PCR kit

 CE mark 7/2020 PCR
Hai Kang Life

C/Tech SARS-CoV-2 RT-PCR kit

 CE mark 7/2020 PCR
Hangzhou AllTest Biotech

2019-nCoV IgG/IgM Rapid Test Cassette

EUA submission pendingCE mark 2/2020 Serological
Hangzhou Biotest Biotech

RightSign COVID-19 IgG/IgM Rapid Test Cassette

EUA 6/4/2020  Serological
Healgen Scientific

2019-nCoV Direct qPCR Kit

 CE mark 4/2020 PCR
Healgen ScientificCOVID-19 IgG/IgM Rapid Test Cassette CE mark 4/2020 Serological
Healgen Scientific/Zhejiang Orient Gene Biotech

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

EUA 5/29/2020   Serological
HealthQuest EsotericsHealthQuest Esoterics TaqPath SARS-CoV-2 AssayEUA 6/23/2020  PCR
HelixHelix COVID-19 NGS Test

EUA 8/6/2020, reissued 10/22/2020

HelixHelix COVID-19 TestEUA 7/23/2020  PCR
HologicPanther Fusion SARS-CoV-2 assayEUA 3/16/2020  PCR

Aptima SARS-CoV-2 assay

EUA 5/14/2020  PCR

COVIDSeq Test 

EUA 6/9/2020  Sequencing


  CE Mark 5/2020 Serological

MutaPLEX Coronavirus 

  CE Mark 4/2020 PCR
InBios International

SCoV-2 Detect IgG ELISA kit 

EUA 6/10/2020  Serological
InBios International

SCoV-2 Detect IgM ELISA kit

EUA 7/1/2020  Serological
InBios International

Smart Detect SARS-CoV-2 rRT-PCR Kit

EUA 4/7/2020  PCR
Inform Diagnostics

Inform Diagnostics SARS-CoV-2 RT-PCR Assay

EUA 6/26/2020  PCR

Innocreate Bioscience

Innocreate SARS-CoV-2 QD kit  Taiwan Food and Drug Administration approvalPCR
Integrated DNA Technologies/DanaherIDT 2019-novel coronavirus kitunder CDC's EUA

Integrity Laboratories

SARS-CoV-2 Assay

EUA 4/13/2020  PCR
Ipsum Diagnostics

COV-19 IDx assay

EUA 4/1/2020  PCR

Jiangsu Bioperfectus Technologies

COVID-19 Coronavirus Real Time PCR Kit

EUA 6/18/2020  PCR

Jiangsu Well Biotech

Orawell IgM/IgG Rapid Test

EUA 9/23/2020  Serological

JN Medsys

ProTect Covid-19 kit

 under CDC's EUACE mark 4/2020Singapore Health Sciences Authority provisional authorization; Philippines FDAPCR
Kaiser Permanente Mid-Atlantic StatesKPMAS COVID-19 TestEUA 6/13/2020  PCR
Kantaro Biosciences

COVID-SeroKlir, COVID-SeroIndex quantitative SARS-CoV-2 IgG antibody test kits

 CE mark 10/2020 Serological
Kephera Diagnostics 


EUA submission pending  Serological
KimForest Enterprise

KimForest SARS-CoV-2 Detection Kit v1

EUA 9/21/2020  PCR
Kogene Biotech

PowerChek 2019-nCoV Real-time PCR Kit

EUA 7/13/2020CE markEUAL, Korea Centers for Disease Control and the Korea Food and Drug AdministrationPCR


Curative-Korva SARS-Cov-2 Assay

EUA 4/16/2020  PCR

Kroger Health

Kroger Health COVID-19 Test Home Collection Kit

EUA 6/30/2020  Home collection kit

LabGun COVID-19 RT-PCR Kit

EUA 4/29/2020  PCR
Laboratorio Clinico ToledoLaboratorio Clinico Toledo SARS-CoV-2 AssayEUA 7/6/2020  PCR
Laboratory Corporation of AmericaCOVID-19 RT-PCR Test

EUA 3/16/2020, reissued 4/20/2020, 7/24/2020, 9/18/2020

LetsGetChecked (PrivaPath Diagnostics)

LetsGetChecked Coronavirus (COVID-19) Test

EUA 5/28/2020  PCR
LGC, Biosearch Technologies

2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2

under CDC's EUA  PCR
LifeHope Labs

LifeHope2019-nCoV Real-Time RT-PCR Diagnostic Panel

EUA 6/29/2020  PCR
Lucira Health

Lucira COVID-19 All-In-One Test Kit

EUA 11/17/2020  LAMP

xMAP SARS-CoV-2 Multi-Antigen IgG Assay

EUA 7/16/2020  Serological


EUA 4/3/2020, amended 5/11/2020  PCR

NxTAGCoV Extended Panel Assay

EUA 3/27/2020  PCR


LumiraDx SARS-CoV-2 RNA STAR Complete

EUA 10/14/2020  PCR


LumiraDx SARS-CoV-2 Ag Test

EUA 8/18/2020  Antigen



EUA 8/11/2020   PCR

Maccura Biotechnology

SARS-CoV-2 Fluorescent PCR Kit

EUA 4/15/2020  PCR

Mammoth Biosciences

SARS-CoV-2 DETECTR Reagent Kit 

EUA 8/31/2020  CRISPR 

Massachusetts General Hospital

MGH COVID-19 qPCR assay

EUA 4/3/2020   PCR
Mayo Clinic Laboratories

SARS-CoV-2 Molecular Detection Assay

EUA 4/20/2020  PCR


 CE mark 5/2020 Serological
MedMiraREVEALCOVID-19 total antibody testEUA submission pendingCE mark 5/2020 Serological
Megna HealthRapid COVID-19 IgM/IgG Combo Test KitEUA 7/17/2020  Serological
Mesa BiotechAccula SARS-CoV-2 testEUA 3/23/2020  PCR

MicroGenDx (Southwest Regional PCR Laboratory)

COVID-19 Key

EUA 3/23/2020  PCR


MiraDx SARS-CoV-2 RT-PCR assay 

EUA 8/31/2020  PCR


Novodiag COVID-19

 CE mark 6/2020 PCR


Amplidiag COVID-19

 CE mark 6/2020 PCR

Mount Sinai Labs

COVID-19 ELISA IgG Antibody Test

EUA 4/15/2020   Serological

MP Biomedicals Asia Pacific

Assure SARS-CoV-2 IgG/IgM rapid test

  Singapore Health Sciences Authority provisional authorizationSerological

Nal von minden

Nadal COVID-19 IgG/IgM test

 CE mark 3/2020 Serological

NanoEntek America

Frend COVID-19 Total Ab

EUA 9/29/2020  Serological

National Jewish Health

SARS-CoV-2 MassArray Test

EUA 9/29/2020  PCR and mass spectrometry

Nationwide Children's Hospital

SARS-CoV-2 Assay

EUA 4/27/2020  PCR

Nebraska Medicine Clinical Laboratory

NEcov19 RT-PCR Assay

EUA 6/4/2020   PCR


Naissa SARS-CoV-2 IgM

 CE Mark 7/2020 Serological


Naissa SARS-CoV-2 IgG

 CE Mark 7/2020 Serological


Naissa SARS-CoV-2 IgA

 CE Mark 7/2020 Serological

NeuMoDx Molecular

NeuMoDx SARS-CoV-2 Assay

EUA 3/30/2020CE mark 5/2020 PCR


NGenePlex nCoV qRT-PCR kit

EUA submission pendingCE mark 7/2020 PCR

Nirmidas Biotech

Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit

EUA 9/29/2020  Serological

Northwestern Medicine Diagnostic Molecular Laboratory

SARS-Cov-2 Assay

EUA 4/2/2020  PCR
Novacyt/PrimerdesignCOVID-19 Genesig Real-Time PCR assayEUA 3/20/2020CE mark 2/2020

EUA, India 3/26/2020

Thailand Ministry of Health, 4/2/2020

NowDiagnosticsAdexusDx COVID-19 Total Antibody Rapid Test CE mark 7/2020 Serological
NY State Department of Health (performed at Wadsworth Center and New York City Department of Health and Mental Hygiene, Public Health Laboratories)New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel EUA 3/10/2020  PCR

Ohio State University Wexner Medical Center


EUA 6/17/2020  PCR

Omnipathology Solutions Medical Corporation

Omni COVID-19 Assay by RT-PCR

EUA 6/17/2020  PCR

Omixon/SeqOnce Biosciences

AzureSeq-200 RT-PCR kit

 CE mark 10/2020 PCR

One Health Laboratories

SARS-CoV-2 Real-Time RT-PCR-Test

EUA 5/13/2020   PCR


Real SARS-CoV-1/2 kit CE mark 10/2020 PCR


SARS-CoV-2 Kit with PULB CE mark 8/2020 PCR

Opti Medical Systems

Opti SARS-CoV-2 RT-PCR kit EUA 5/6/2020CE mark 6/2020 PCR

Optolane Technologies

Kaira 2019-nCoV Detection kit

EUA 9/1/2020CE mark 4/2020 PCR


Orig3n 2019 Novel Coronavirus (COVID-19) Test

EUA 4/10/2020  PCR

Ortho Clinical Diagnostics

Vitros SARS-CoV-2 Antigen test

 CE mark 10/2020 Antigen

Ortho Clinical Diagnostics

Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test

 CE mark 5/2020 Serological

Ortho Clinical Diagnostics

Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators

EUA 4/14/2020, amended 5/9/2020

CE mark 5/2020 Serological
Ortho Clinical Diagnostics

Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack/Calibrator

EUA 4/24/2020

Osang HealthcareGeneFinder COVID-19 Plus RealAmp KitEUA 4/18/2020CE mark 2/2020 PCR
Oxford Nanopore Technologies


 CE mark 10/2020 LAMP, sequencing
P23 Labs

P23 Labs TaqPath SARS-CoV-2 Assay

EUA 5/21/2020, reissued 10/20/2020

PathoFinderRespiFinder 2Smart kit CE mark 11/2020 PCR

RealAccurate Quadriplex (RAQ) Flu/COVID-19 PCR kit

 CE mark 11/2020 PCR

RealAccurate Quadruplex Corona-plus PCR Kit

 CE mark 4/2020 PCR

RealAccurate Quadruplex SARS-CoV-2 PCR Kit

 CE mark 6/2020 PCR

Patients Choice Laboratories

PCL SARS-CoV-2 Real-Time RT-PCR Assay

EUA 8/28/2020   PCR 

PKamp Respiratory SARS-CoV-2 RT-PCR Panel

 CE mark 10/2020 PCR

SuperFlex Anti-SARS-CoV-2 IgG kit

 CE mark 7/2020 Serological

PerkinElmer GSP/DELFIA Anti-SARS-CoV-2 IgG kit

 CE mark 7/2020 Serological

PerkinElmer SARS-CoV-2 RT-PCR Asssay

 CE mark 11/2020 PCR

SARS-CoV-2 RT-qPCR Reagent Kit

 CE mark 4/2020 PCR

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

EUA 3/24/2020, reissued 10/28/2020  PCR
Phosphorus Diagnostics

Phosphorus COVID-19 RT-qPCR Test

EUA 6/4/2020  PCR

IntelliPlex SARS-CoV-2 Detection Kit

EUA 6/25/2020CE mark 5/2020 PCR
Poplar Healthcare

Poplar SARS-CoV-2 TMA Pooling assay

EUA 8/3/2020  Isothermal amplification

FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)

EUA 6/25/2020  PCR

Progenika Biopharma/Grifols

Anti-SARS-CoV-2 (IgG) ELISA Kit

 CE mark 9/2020 Serological
Pro-Lab Diagnostics

Pro-AmpRT SARS-CoV-2 Test

EUA 8/13/2020  Isothermal amplification
ProterixBioSARS-CoV-2 (RBD) IgG Antibody testEUA submission pending  Serological
PsomagenPsoma COVID-19 RT TestEUA 6/30/2020  PCR
QDx Pathology ServicesQDX SARS-CoV-2 AssayEUA 8/25/2020  PCR
QiagenQiaStat-Dx Respiratory SARS-CoV-2 PanelEUA 3/30/2020CE mark 3/2020 PCR
Quadrant Biosciences

Clarifi COVID-19 Test Kit

EUA 9/22/2020  PCR

Quansys Biosciences

Q-Plex SARS-CoV-2 Human IgG (4 Plex)

EUA 10/28/2020  Serological
QuantuMDxSARS-CoV-2 RT-PCR Detection AssayEUA submission pendingCE mark 6/2020 PCR
Quest Diagnostics Infectious DiseaseQuest Diagnostics HA SARS-CoV-2EUA 7/15/2020  PCR
Quest Diagnostics Infectious DiseaseQuest Diagnostics RC SARS-CoV-2 AssayEUA 7/15/2020  PCR
Quest Diagnostics Infectious DiseaseQuest Diagnostics PF SARS-CoV-2 AssayEUA 7/15/2020  PCR
Quest DiagnosticsCoronavirus Disease 2019 (COVID-19) TestEUA 3/17/2020, reissued 7/18/2020  PCR

Sofia 2 Flu + SARS Antigen FIA

EUA 10/2/2020  Antigen
QuidelSofia 2 SARS Antigen FIAEUA 5/8/2020CE mark 7/2020 Antigen
QuidelLyra SARS-CoV-2 AssayEUA 3/17/2020, amended 3/23/2020CE mark 3/2020 PCR


Lyra Direct SARS-CoV-2 Assay

EUA 5/18/2020CE mark 5/2020 PCR

Quotient Limited/Quotient Suisse

MosaiQ COVID-19 Antibody Magazine

EUA 9/25/2020CE mark 5/2020 Serological


Rida Gene SARS-CoV-2

 CE mark 5/2020 PCR

Rendu Biotechnology

2019-nCoV detection kit

  China NMPA 3/2020Isothermal amplification
RheonixRheonix COVID-19 MDx AssayEUA 4/29/2020  PCR

Cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test (for Cobas Liat system)

EUA 9/14/2020  PCR

Cobas SARS-CoV-2 & Influenza A/B

EUA 9/3/2020   PCR

Elecsys Anti-SARS-CoV-2

EUA 5/2/2020  Serological
RocheCobas SARS-CoV-2 Test

EUA 3/12/2020, reissued 10/15/2020

CE mark 2020 PCR

RTA Laboratories

Diagnovital SARS-CoV-2 Real-Time PCR Kit

EUA 6/12/2020  PCR

Rutgers University Clinical Genomics Laboratory

ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit

EUA 4/10/2020, amended 5/7/2020  PCR


Sienna-Clarity Coviblock COVID-19 IgG/IgM Rapid Test Cassette

EUA 7/13/2020  Serological

Sandia National Laboratories

SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay

EUA 7/27/2020  PCR

Sansure BioTech

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

EUA 5/4/2020   PCR

ScienCell Research Laboratories

ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit

EUA 4/3/2020  PCR
SD Biosensor

Standard M nCoV Real-Time Detection Kit

EUA 4/23/2020  PCR
SD Biosensor

Standard Q COVID-19 IgM/IgG Duo Test

Seasun Biomaterials

AQ-TOP COVID-19 Rapid Detection Kit Plus

EUA 10/5/2020  Isothermal amplification
Seasun Biomaterials

U-TOP COVID-19 Detection Kit

EUA 4/27/2020  PCR
Seasun Biomaterials

AQ-TOP COVID-19 Rapid Detection Kit

EUA 5/21/2020  Isothermal amplification
SeegeneAllplex 2019-nCoV AssayEUA 4/21/2020CE mark 2/2020EUA, Korea Ministry of Food and Drug SafetyPCR

Sentinel Diagnostics

STAT-NAT COVID-19 HK kit, B kit CE mark 3/2020 PCR

SeqOnce Biosciences

AzureSeq SARS-CoV-2 RT-qPCR KitEUA submission pending  PCR

Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical


novel coronavirus nucleic acid detection kit

 CE mark 3/2020China NMPA 3/2020PCR

Shenzhen New Industries Biomedical Engineering (SNIBE)

Maglumi2019-nCoV IgM/IgG

EUA 9/14/2020   Serological

Sherlock Biosciences

Sherlock CRISPR SARS-CoV-2 kit

EUA 5/6/2020  CRISPR
Siemens Healthineers

SARS-CoV-2 IgG Antibody Test

EUA submission pendingCE mark 11/2020 Serological
Siemens Healthineers

Clinitest Rapid COVID-19 Antigen Test

 CE mark 10/2020 Antigen
Siemens Healthineers

Atellica IM SARS-CoV-2 Total (COV2T)

EUA 5/29/2020CE mark 5/2020 Serological
Siemens Healthineers

Atellica IM SARS-CoV-2 IgG (COV2G)

EUA 7/31/2020  Serological
Siemens Healthineers

Advia Centaur SARS-CoV-2 Total (COV2T)

EUA 5/29/2020CE mark 5/2020 Serological
Siemens Healthineers

Advia Centaur SARS-CoV-2 IgG (COV2G)

EUA 7/31/2020  Serological
Siemens HealthineersDimension EXL SARS-CoV-2 EUA 6/8/2020  Serological
Siemens HealthineersDimension Vista SARS-CoV-2 EUA 6/8/2020  Serological
Siemens Healthineers/Fast Track Diagnostics
Fast Track Diagnostics (FTD) SARS-CoV-2 AssayEUA 5/5/2020CE mark 4/2020 PCR
Snibe DiagnosticsMaglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits CE mark 2/2020 Serological
Snibe Diagnostics

Maglumi SARS-CoV-2 S-RBD IgG kit

 CE mark 8/2020 Serological
Solaris Diagnostics

Solaris Multiplex SARS-CoV-2 Assay

EUA 8/10/2020   PCR

DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit

EUA 5/21/2020  CE mark 2/2020EUA, Korea Ministry of Food and Drug Safety; Philippines FDAPCR

Sona Nanotech

COVID-19 rapid antigen test

EUA submission pending  Antigen

Sorrento Therapeutics

COVI-Track Diagnostic Test

EUA submission pending  Serological

Specialty Diagnostic (SDI) Laboratories

SDI SARS-CoV-2 Assay

EUA 4/10/2020   PCR
Spectrum SolutionsSDNA-1000 Saliva Collection DeviceEUA 10/8/2020  Collection device
Stanford Health Care Clinical Virology LaboratorySARS-CoV-2 PCR AssayEUA 4/8/2020  PCR

SGTi-flex COVID-19 IgG

EUA 9/3/2020  Serological
SureScreen DiagnosticsSureScreen COVID19 IgM/IgG Rapid Test Cassette CE mark 2020 Serological

HISCL SARS-CoV-2 Ag Reagent


Japan IVD approval for manufacturing and marketing

Systaaq Diagnostic Products2019-Novel Coronavirus (COVID-19) Real Time PCR Kit CE mark 3/2020 PCR
T2 Biosystems

T2SARS-CoV-2 Panel

EUA 8/31/2020   PCR 
Tataa Biocenter

TATAA GrandPerformance SARS-CoV-2 detection kit

 CE mark 3/2020 PCR
TBG Biotechnology

TBG SARS-CoV-2 IgG/IgM Rapid Test Kit 

EUA 8/31/2020CE mark 5/2020 India CDSCO 10/2020Serological
TBG Biotechnology

ExProbe SARS-CoV-2 Testing Kit 

EUA 6/10/2020CE mark 5/2020 Taiwan FDA 7/2020, India CDSCO 10/2020PCR

Tempus Labs

iC SARS-CoV2 Test

EUA 10/1/2020  PCR

Texas Department of State Health Services

Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay

EUA 8/21/2020  PCR
Thermo Fisher Scientific

EliA SARS-CoV-2-Sp1 IgG test

 CE mark 10/2020 Serological
Thermo Fisher Scientific

OmniPath COVID-19 Total Antibody ELISA Test

EUA 10/2/2020CE mark 10/2020 Serological
Thermo Fisher Scientific

TaqPath COVID-19 Combo Kit, RT-PCR CE-IVD Kit

EUA 3/13/2020 (Combo kit), reissued 10/9/2020CE mark 3/2020 (CE-IVD kit)Authorization in Australia, Singapore, Taiwan (Combo kit)PCR
TIB Molbiol SyntheselaborSarbecovirus E-gene CE mark 2/2020 PCR
Tide LaboratoriesDTPM COVID-19 RT-PCREUA 6/10/2020  PCR
TNS (BioTNS)COVID-19 RT-PCR Peptide Nucleic Acid (PNA) KitEUA 6/30/2020CE mark 5/2020 PCR
Trax Management ServicesPhoenix Dx 2019-CoVEUA 4/20/2020  PCR

Trax Management Services

Phoenix Dx SARS-CoV-2 Multiplex

EUA 7/13/2020  PCR

UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin


EUA 7/9/2020  CRISPR

Ultimate Dx Laboratory

UDX SARS-CoV-2 Molecular Assay

EUA 4/20/2020  PCR

UMass Memorial Medical Center

UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel

EUA 10/1/2020  PCR

University of Alabama at Birmingham Fungal Reference Lab

FRL SARS CoV-2 TestEUA 6/23/2020  PCR

University of Arizona Genetics Core for Clinical Services

COVID-19 ELISA pan-Ig Antibody Test 

EUA 8/31/2020  Serological

University of California, Los Angeles

UCLA SwabSeq COVID-19 Diagnostic Platform

EUA 10/6/2020  PCR

University of California San Diego Health


EUA 7/31/2020  PCR

University of North Carolina Medical Center

UNC Health SARS-CoV-2 real-time RT-PCR test

EUA 4/10/2020   PCR

University of Texas MD Anderson Cancer Center Molecular Diagnostics Laboratory

MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay

EUA 6/25/2020  PCR

UTMG Pathology Laboratory


EUA 5/3/2020   PCR

Vela Diagnostics

ViroKey SARS-CoV-2 RT-PCR Test v2.0

EUA 9/22/2020

CE mark 7/2020


Vela Diagnostics

ViroKey SARS-CoV-2 RT-PCR Test

EUA 8/5/2020

CE mark 4/2020

Singapore Health Sciences Authority provisional authorization

Veredus Laboratories

VereCoV OneMix Detection Kit

 pendingSingapore Health Sciences Authority provisional authorization  10/2020PCR, microarray
Veredus Laboratories

VereRT COVID-19 PCR Kit (previously VereRTCoV SARS-CoV-2 Real-Time RT-PCR)

 CE mark 6/2020 (pending for updated product)Singapore Health Sciences Authority provisional authorization  6/2020PCR

Veredus Laboratories

VereRT ZeroPrep COVID-19 PCR Kit (previously VereRTCoV 3.0 ZeroStep Real-Time RT-PCR)

 CE mark 8/2020 (old product name)Singapore Health Sciences Authority provisional authorization 8/2020PCR

Veredus Laboratories

VereCoV Detection Kit 

 CE mark 3/2020

Singapore Health Sciences Authority provisional authorization 2/2020


Verily Life Sciences

Verily COVID-19 RT-PCR TestEUA 9/8/2020  PCR

Vibrant America Clinical Labs

Vibrant COVID-19 Ab AssayEUA 6/4/2020  Serological

Viracor Eurofins

Viracor SARS-CoV-2 assayEUA 4/6/2020  PCR

Visby Medical

Visby Medical COVID-19EUA 9/16/2020  PCR

Vision Medicals

SARS-CoV-2 Clinical Sequencing assay CE mark 3/2020 PCR

Wadsworth Center, New York Department of Health

New York SARS-CoV Microsphere Immunoassay for Antibody Detection

EUA 4/30/2020   Serological

Warrior Diagnostics

Warrior Diagnostics SARS-CoV-2 Assay

EUA 6/9/2020  PCR

Wren Laboratories

Wren Laboratories COVID-19 PCR Test

EUA 8/3/2020, reissued 10/20/2020


Xiamen Biotime Biotechnology

Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test

EUA 7/24/2020  Serological

Xiamen Wiz Biotech

Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2

 CE mark 3/2020 Serological

Xiamen Zeesan Biotech

SARS-CoV-2 Test Kit (Real-time PCR)

EUA 7/31/2020   PCR

Yale New Haven Hospital Clinical Virology Laboratory

SARS-CoV-2 PCR test

EUA 3/31/2020  PCR

Yale School of Public Health


EUA 8/15/2020, reissued 8/28/2020


YD Diagnostics

MolecuTech Real-Time COVID-19

EUA submission pendingCE mark 3/2020India 4/2020PCR

Yourgene Health

Clarigene SARS-CoV-2 CE mark 8/2020 PCR

Zeus Scientific

Zeus ELISA SARS-CoV-2 IgG Test System

EUA 10/6/2020  Serological

Zhejiang Orient Gene Biotech

Coronavirus Ag Rapid Test Cassette CE mark 7/2020 Antigen

Zhejiang Orient Gene Biotech

COVID-19 IgG/IgM Rapid Test Cassette CE mark 4/2020 Serological

Zhejiang Orient Gene Biotech

Coronavirus Detection Kit  CE mark 4/2020 PCR

Zhejiang Orient Gene Biotech

2019-nCoV and SARS-CoV Detection Kit CE mark 4/2020 PCR

Zhejiang Orient Gene Biotech

SARS-CoV-2 Detection Kit CE mark 4/2020 PCR

Zhuhai Lituo Biotechnology

COVID-19 Antigen Detection Kit (Colloidal Gold)

 CE mark 7/2020 Antigen

ZhuHai Sinochips Bioscience

COVID-19 Nucleic Acid RT-PCR Test Kit

EUA 8/17/2020  PCR

Zymo Research

Quick SARS-CoV-2 Multiplex Kit

 CE mark 11/2020 PCR

Zymo Research

Quick SARS-CoV-2rRT-PCR Kit

EUA 5/7/2020 CE mark 7/2020 PCR

The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.

The point-of-care test is designed for the qualitative presumptive detection of specific IgM and IgG antibodies to SARS-CoV-2 in a fingerstick blood sample.

The test, which uses an Applied Bioystems TaqPath assay and real-time PCR technology, detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19.

Now, the assay can also be used with the Applied Biosystems 7500 Standard from Thermo Fisher Scientific, Roche's LightCycler 480, and Qiagen's Rotor-Gene Q.

The company has issued a call for the 2,500 independent MDx labs across the US to join together in an effort to double SARS-CoV-2 testing capacity.

After a recent consumer alert from the US Food and Drug Administration, the startup is modifying its sample collection process to only support physician in-person specimen collection. 

The rapid one-step Anti-SARS-CoV-2 Rapid Test detects IgG and IgM antibodies to SARS-CoV-2 and was developed by Autobio.

The company, known for clinical chemistry and molecular biology diagnostic kits, is currently working on two test kits for SARS-CoV-2.

Yourgene will use its manufacturing facility at Citylabs in Manchester to ramp up production of the test, which was developed by Novacyt's Primerdesign division.

OpGen also reported full-year growth was driven by revenue increases for its Acuitas AMR Gene Panel and Acuitas Lighthouse informatics platform.