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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: August 5, 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
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 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

EUA submission pendingCE mark 5/2020 PCR

Agena Bioscience

SARS-CoV-2 Panel

EUA submission pending  PCR

AIT Laboratories

SARS-CoV-2 Assay

EUA 4/24/2020  PCR
Akston Biosciences


EUA submission pending  Serological
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
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
Anatolia GeneworksBosphore Novel Coronavirus (2019-nCoV) Detection Kit CE mark 2/2020 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 TestEUA 4/24/2020CE 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

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 Company

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
BGIReal-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoVEUA 3/26/2020CE mark 3/2/2020China NMPA 1/2020PCR


SARS-CoV-2 TestEUA 4/28/2020  PCR

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

Biohit Healthcare (Hefei)

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

EUA 6/18/2020  Serological


2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)

EUA submission pendingCE mark 4/2020

Singapore Health Sciences Authority provisional authorization; Philippines FDA



COVID-19 IgM-IgG Rapid Test

 CE mark 3/2020 Serological

COVID-19 IgG/IgM Rapid Test

 CE mark 5/2020 Serological

Vidas anti-SARS-CoV-2 IgM test

 CE mark 5/2020 Serological
BioMérieuxVidas anti-SARS-CoV-2 IgG test 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 (RP2.1) (EUA)

BioFire Respiratory Panel 2.1 plus (CE mark)

EUA 5/1/2020 CE mark 7/2020 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  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  PCR


FluoroType SARS-CoV-2 plus

 CE mark 5/5/2020 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
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

SARS-CoV-2 RT-PCR test

EUA 7/1/2020  PCR

Xpert Xpress SARS-CoV-2 test

EUA 3/20/2020  PCR
CerTest BioTecViaSure SARS-CoV-2 Real Time PCR Detection Kit CE mark 3/2020 on the Becton Dickinson 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
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute

Cleveland Clinic SARS-CoV- Assay

EUA 8/3/2020  PCR
Clinical Reference Laboratory

CRL Rapid Response

EUA 7/30/2020  Molecular

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

EUA 4/3/2020CE mark 2/2020 PCR


Color SARS-CoV-2 LAMP Diagnostic Assay

EUA 5/18/2020, amended 7/24/2020  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 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
Dba SpectronRx

Hymon SARS-CoV-2 Test Kit

EUA 5/22/2020  PCR

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 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
Eli Lilly

Lilly SARS-CoV-2 Assay

EUA 7/27/2020  PCR
Emory Medical Laboratories

SARS-CoV-2 RBD IgG test

EUA 6/15/2020  Serological
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


EUA submission pendingCE 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

Anti-SARS-CoV-2 ELISAs (IgA and IgG)

 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 submission pending  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

EUA submission pending  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
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

Genetron SARS-CoV-2 RNA Test

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

ePlex SARS-CoV-2 Test

EUA 3/19/2020  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 submission pendingCE mark 5/2020 Serological



EUA 4/16/2020   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 assaysEUA submission pending
CE mark 4/2020 Serological

Gravity Diagnostics

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

Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory

CDI Enhanced COVID-19 Test

EUA 4/15/2020  PCR
Hai Kang Life


 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/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 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
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
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

JN Medsys

ProTect Covid-19 kit

 under CDC's EUACE mark 4/2020Singapore Health Sciences Authority provisional authorization; Philippines Food and Drug AdministrationPCR
Kaiser Permanente Mid-Atlantic StatesKPMAS COVID-19 TestEUA 6/13/2020  PCR
Kephera Diagnostics 


EUA submission pending  Serological
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 TestEUA 3/16/2020, reissued 4/20/2020, amended 7/24/2020  PCR
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

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

Maccura Biotechnology

SARS-CoV-2 Fluorescent PCR Kit

EUA 4/15/2020  PCR

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


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

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

NeuMoDx Molecular

NeuMoDx SARS-CoV-2 Assay

EUA 3/30/2020CE mark 5/2020 PCR

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

One Health Laboratories

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

EUA 5/13/2020   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

 CE mark 4/2020 PCR


Orig3n 2019 Novel Coronavirus (COVID-19) Test

EUA 4/10/2020  PCR

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
P23 Labs

P23 Labs TaqPath SARS-CoV-2 Assay

EUA 5/21/2020  PCR

RealAccurate Quadruplex Corona-plus PCR Kit

 CE mark 4/2020 PCR

RealAccurate Quadruplex SARS-CoV-2 PCR Kit

 CE mark 6/2020 PCR

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 New Coronavirus Nucleic Acid Detection Kit

EUA 3/24/2020CE mark 3/2020 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
PsomagenPsoma COVID-19 RT TestEUA 6/30/2020  PCR
QiagenQiaStat-Dx Respiratory SARS-CoV-2 PanelEUA 3/30/2020CE mark 3/2020 PCR
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
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

MosaiQ COVID-19 Antibody Microarray

 CE 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

Elecsys Anti-SARS-CoV-2

EUA 5/2/2020  Serological
RocheCobas SARS-CoV-2 TestEUA 3/12/2020CE 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

EUA submission pending  Serological
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

Sherlock Biosciences

Sherlock CRISPR SARS-CoV-2 kit

EUA 5/6/2020  CRISPR
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

DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit

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

Sorrento Therapeutics

COVI-Track Diagnostic Test

EUA submission pending  Serological

Specialty Diagnostic (SDI) Laboratories

SDI SARS-CoV-2 Assay

EUA 4/10/2020   PCR
Stanford Health Care Clinical Virology LaboratorySARS-CoV-2 PCR AssayEUA 4/8/2020  PCR
SureScreen DiagnosticsSureScreen COVID19 IgM/IgG Rapid Test Cassette CE mark 2020 Serological
Systaaq Diagnostic Products2019-Novel Coronavirus (COVID-19) Real Time PCR Kit CE mark 3/2020 PCR
Tataa Biocenter

TATAA GrandPerformance SARS-CoV-2 detection kit

 CE mark 3/2020 PCR
TBG Biotechnology

ExProbe SARS-CoV-2 Testing Kit 

EUA 6/10/2020  PCR
Thermo Fisher Scientific

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

EUA 3/13/2020 (Combo kit), amended 3/24/2020, 4/20/2020, 5/9/2020CE 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

University of Alabama at Birmingham Fungal Reference Lab

FRL SARS CoV-2 TestEUA 6/23/2020  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 5/1/2020   PCR

Vela Diagnostics

ViroKey SARS-CoV-2 RT-PCR Test


CE mark 4/2020

CE mark 7/2020 (automated version)

Singapore Health Sciences Authority provisional authorization


Veredus Laboratories

VereCoV Detection Kit 

 CE mark 3/2020

Singapore Health Sciences Authority provisional authorization 2/2020


Vibrant America Clinical Labs

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

Viracor Eurofins

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

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

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

Zhejiang Orient Gene Biotech

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

Zymo Research

Quick SARS-CoV-2rRT-PCR Kit

EUA 5/7/2020   PCR

The firm said declines across most business areas were slightly offset by increases in sales of sample collection devices.

The company said that in response to the letter, it is recalling all non-Luminex temperature verification fixtures from the field for its Verigene SP instrument.

Company officials credited investments in information technology, as well as R&D for RT-PCR-based tests, with driving up the firm's billable testing numbers.

The governors of the six states are collaborating with the Rockefeller Foundation to expand access to point-of-care antigen testing for SARS-CoV-2.

COVID-19 testing at Frankfurt Airport

Germany's Federal Ministry of Health issued an order last Friday making testing freely available to returning travelers within 72 hours of entering the country.

The tests use a range of different specimens including self-collected nasal swabs, bronchoalveolar lavage, sputum, and nasopharyngeal washes.

The genetic testing company said its orders for traditional tests have also rebounded and are on track for growth in the second half of 2020.

GenMark has two SARS-CoV-2 tests that have received FDA Emergency Use Authorization, including a respiratory panel that tests for 21 pathogens.

The firm delivered record revenue and the most profitable quarter in its history as a result of the increased demand for its products.

On an adjusted basis at constant exchange rates, revenues grew 19 percent year over year, in line with guidance provided by the company in early July.