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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. This table is updated to the best of our ability and may not include every commercially available test. 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: October 15, 2024

 

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

 

Company/Organization
Name
Test Name US Regulatory Status* EU Regulatory Status Asia/Canada Regulatory Status Technology
1drop

1copy COVID-19 qPCR Multi Kit

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

TRUPCR SARS-CoV-2 Kit

EUA 6/18/2020, reissued 12/17/2020

    PCR
3D Medicines

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

  CE mark 3/2020   PCR
3EO Health 3EO Health COVID-19 Test EUA 9/19/2023     Isothermal amplification
Abacus Diagnostica

GenomEra SARS-CoV-2 Assay

  CE mark 7/2020   PCR
Abacus Diagnostica  GenomEra SARS-CoV-2 2.0 Assay    CE mark 2/2022   PCR
Abbott Panbio Rapid Antigen Self-Test   CE mark 6/2021   Antigen
Abbott

Alinity m Resp-4-Plex

EUA 3/4/2021 CE mark   PCR
Abbott

Alinity m SARS-CoV-2 assay

EUA 12/23/2020     PCR
Abbott

SARS-CoV-2 IgG II Quant antibody test

  CE mark 12/2020   Serological
Abbott

Advise SARS-CoV-2 IgG II

EUA 3/1/2021     Serological
Abbott

AdviseDx SARS-CoV-2 IgM

EUA 10/9/2020     Serological
Abbott

BinaxNow COVID-19 Antigen Self Test

EUA 3/31/2021

    Antigen
Abbott

BinaxNow COVID-19 Ag Card2 Home Test

EUA 3/31/2021, revoked 2/24/2022

    Antigen
Abbott

BinaxNow COVID-19 Ag 2 Card

EUA 3/31/2021

    Antigen
Abbott

BinaxNow COVID-19 Ag Card

EUA 8/26/2020, reissued 12/16/2020. Revoked 1/31/2023.

    Antigen
Abbott SARS-CoV-2 IgG test

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

    Serological
Abbott ID Now COVID-19 EUA 3/27/2020     Isothermal amplification
Abbott ID Now COVID-19 2.0 EUA 5/6/2022     Isothermal amplification
Abbott Abbott RealTime SARS-CoV-2 EUA test EUA 3/18/2020     PCR
Abionic IVD Capsule COVID-19 Test   CE mark 11/2021   Antigen
Access Bio CareStart COVID-19 Antigen Home Test EUA 8/2/2021     Antigen

Access Bio

CareStart COVID-19 Antigen test

EUA 10/8/2020 CE mark 9/2020   Antigen
Access Bio CareStart EZ COVID-19 IgM/IgG EUA 6/24/2021     Serological

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

OraRisk COVID-19 RT-PCR

EUA 7/17/2020     PCR
Achiko AptameX   CE mark 5/2022   Aptamer
Acon Laboratories Flowflex COVID-19 Antigen Home Test EUA 10/4/2021     Antigen

Acon Laboratories

Acon SARS-CoV-2 IgG/IgM Rapid Test

EUA 12/15/2020     Serological
Actim Actim SARS-CoV-2 rapid test   CE mark 5/2021   Antigen

Acupath Laboratories

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

EUA 6/29/2020     PCR

ADS Biotec

COVID-19 Rapid Antigen Test

  CE mark 1/2021   Antigen

Advaite

RapCov Rapid COVID-19 Test

EUA 1/11/2021     Serological
Advanced Biological Laboratories DeepChek Whole Genome SARS-CoV-2 Genotyping Assay   CE mark 5/2021   Sequencing
Advanced Biological Laboratories UltraGene SARS-CoV-2 Triplex Assay   CE mark 4/2021   PCR

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

  CE mark 12/2020

Taiwan EUA 8/2020

Indian Council of Medical Research validation 9/2020

Singapore Health Sciences Authority provisional authorization 12/2020

Antigen

Agena Bioscience

MassArray SARS-CoV-2 Panel

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

Agilent Technologies

Agilent SARS-CoV-2 qRT-PCR Dx kit

  CE mark 3/2021   PCR

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, revoked 12/8/2021     PCR
Alimetrix

Alimetrix SARS-CoV-2 RT-PCR Assay

EUA 9/30/2020     PCR, microarray
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 4/22/2020 CE mark 4/2020   PCR
Amazon/SDS Lab Holdco Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test EUA 8/11/2021; revoked 7/19/2022     PCR
Amazon/SDS Lab Holdco Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test EUA 8/11/2021; revoked 7/19/2022     PCR
Amazon/SDS Lab Holdco Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 EUA 5/28/2021; revoked 7/19/2022     PCR
Amazon/SDS Lab Holdco

Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2

EUA 3/25/2021     PCR
Ambry Genetics

Ambry COVID-19 RT-PCR Test

EUA 1/22/2021  

 

PCR
AMSBIO

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

EUA submission pending CE mark 7/2020

Korea Ministry of Food and Drug Safety EUA 7/2020

Philippines FDA 9/2020

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

AniCon Labor

Kylt SARS-CoV-2Complete RTU

  CE mark 6/2020   PCR
ANP Technologies NIDS COVID-19 Antigen Rapid Test Kit EUA 9/24/2021     Antigen
AnteoTech EuGeni COVID-19 Antigen Rapid Test (ART)   CE mark 4/2021, updated 5/2022   Antigen
Applied BioCode BioCode CoV-2 Flu Plus Assay EUA 12/15/2021     PCR

Applied BioCode

BioCode SARS-CoV-2 Assay

EUA 6/15/2020, reissued 12/7/2020     PCR

Applied DNA Sciences

Linea COVID-19 RT-PCR test

EUA 5/13/2020, revoked 4/20/2022     PCR
ArcDia International MariPOC 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 DTC

EUA 2/13/2021     PCR
Assurance Scientific Laboratories

Assurance SARS-CoV-2 Panel

EUA 5/15/2020     PCR

Assure Tech

FaStep COVID-19 Rapid Antigen Test Device

    Health Canada Antigen

Assure Tech

EcoTest COVID-19 Antigen Rapid Test

    Health Canada Antigen

Assure Tech

EcoTest COVID-19 IgM/IgG Antibody Rapid Test

    Health Canada Serological

Assure Tech

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 authorization PCR

Atila BioSystems

iAMP COVID-19 Detection Kit

EUA 4/10/2020     Isothermal amplification
Audere HealthPulse@home kit EUA 11/30/2021     Collection kit
Audere HealthPulse@home Fusion EUA 4/26/2022     Collection kit
AusDiagnostics

AusDiagnostics SARS-CoV-2, influenza, RSV panel

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

EUA 4/24/2020

EUA revoked 8/6/2020

CE mark   Serological
Avacta Life Sciences AffiDX SARS-CoV-2 Antigen Lateral Flow Test  

CE mark 5/2021

CE mark 12/2021 (self-test)

  Antigen
Avellino Lab Avellino 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, revoked 2/14/2023     Serological
Baebies Finder SARS-CoV-2    CE mark 3/2022   PCR

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

COVID-19 RT-PCR Test

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 IgG II

EUA 3/22/2021     Serological

Beckman Coulter

Access SARS-CoV-2 IgM

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

Beckman Coulter

Access SARS-CoV-2 IgG

EUA 6/26/2020 CE mark 6/2020   Serological
Becton Dickinson BD Veritor At-Home COVID-19 Test EUA 8/24/2021, revoked 6/15/2023     Antigen

Becton Dickinson

BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B

EUA 3/24/2021     Antigen

Becton Dickinson

BD SARS-CoV-2/Flu Assay

EUA 2/10/2021; revoked 7/29/2022 CE mark 5/2022   PCR

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, revoked 12/8/2021     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 ELISA EUA 8/5/2020     Serological

Beijing Wantai Biological Pharmacy Enterprise

Wantai SARS-CoV-2 Ab Rapid Test

EUA 7/10/2020     Serological
Beroni Group

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

  CE mark 12/2020   Antigen
Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit   CE mark 4/2020   Serological
Beroni Group COVID-19 Antigen Rapid Test Kit - Colloidal Gold Method   CE mark 6/2022   Antigen
BforCure Bfast [SARS-CoV-2] RT-PCR kit   CE mark 10/2021   PCR
BGI (BGI PathoGenesis Pharmaceutical Technology) SARS-CoV-2 and Influenza A/B RT-PCR Kits   CE mark 9/2020   PCR
BGI Real-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoV EUA 3/26/2020 CE mark 3/2/2020 China NMPA 1/2020 PCR

BillionToOne

qSanger-COVID-19 Assay

EUA 9/4/2020, revoked 3/10/2022     Sequencing

Binx Health

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

EUA 10/20/2020     Collection kit
Biobase Biodustry 2019-nCOV IgM/IgG Antibody Test Kit (Colloidal Gold)   CE mark 3/2020   Serological
Biobase Biodustry SARS-CoV-2 Antigen Test Kit (Colloidal Gold)   CE mark   Antigen

Biocan Diagnostics

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

EUA 8/25/2020     Serological
Biocartis Idylla SARS-CoV-2/Flu/RSV Panel   CE mark 8/2021   PCR

Biocartis

Idylla SARS-CoV-2 Test EUA submission pending CE mark 11/2020   PCR

Biocerna

SARS-CoV-2 Test EUA 4/28/2020     PCR

Biocheck/Accelerate Diagnostics

BioCheck SARS-CoV-2 IgM Antibody Test Kit EUA 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 Test EUA 8/17/2020     Serological

Biocollections Worldwide

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

BioCore

BioCore 20019-nCoV Real Time PCR Kit

EUA 5/21/2020     PCR

Biodesix

 

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

EUA submission pending     PCR
BioEcho Life Sciences EchoLution Viral RNA/DNA Swab Kit   CE mark 5/2021   Collection Kit

Bioeksen R&D Technologies

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

EUA 9/2/2020     PCR

BioGx

Xfree COVID-19 Direct RT-PCR test

EUA 6/29/2021     PCR

Biohit Healthcare (Hefei)

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

EUA 6/18/2020 CE mark 3/2020   Serological
BioLytical Laboratories iStatis COVID-19 Antigen Test     Health Canada authorization 3/2022 Antigen
BioLytical Laboratories iStatis COVID-19 Antigen Home Test   CE mark 3/2022 Health Canada authorization 4/2022 Antigen

BioMedomics

COVID-19 IgM-IgG Rapid Test

  CE mark 3/2020   Serological
Biomeme

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

EUA 8/11/2020     PCR
Biomerica

COVID-19 Rapid Antigen Test

  CE mark 1/2021   Antigen
Biomerica

COVID-19 IgG/IgM Rapid Test

  CE mark 5/2020   Serological
BioMérieux Vidas SARS-COV-2 IgG II   CE mark 5/2021   Serological
BioMérieux

Vidas anti-SARS-CoV-2 IgM test

EUA 8/6/2020, revoked 1/31/2024 CE mark 5/2020   Serological
BioMérieux Vidas anti-SARS-CoV-2 IgG test EUA 8/6/2020, revoked 1/31/2024 CE mark 5/2020   Serological
BioMérieux

SARS-COV-2 RESPI R-GENE test

  CE mark 12/2020   PCR
BioMérieux 

SARS-COV-2 R-GENE test

EUA 5/6/2020, revoked 12/17/2021 CE mark 4/10/2020   PCR

BioMérieux/BioFire Defense

BioFire COVID-19 test

EUA 3/23/2020, reissued 12/4/2020     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, replaced by de novo premarket authorization 3/17/2021

revoked 3/17/2021

CE mark 7/2020   PCR
Bioneer

AccuPower RV1 Multiplex Kit

  CE mark 11/2020   PCR
Bioneer  AccuPower COVID-19 Real-Time RT-PCR Kit, AccuPower SARS-CoV-2 Real-Time RT-PCR Kit   CE mark 3/2020   PCR
Bioneer

AccuPower RV1 Real-Time RT-PCR Kit

  CE mark 11/2020   PCR
Biopanda Reagents

COVID-19 Rapid Antibody Test

  CE mark 3/2020   Serological
Biopix-T COV19 qcLAMP kit   CE mark 10/2021   Isothermal amplification
Bio-Rad Laboratories BioPlex 2200 SARS-CoV-2 IgG EUA 7/1/2021, revoked 1/11/2022      Serological
Bio-Rad Laboratories

Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit

EUA 2/11/2021, revoked 4/14/2022 CE mark 7/2021   PCR
Bio-Rad Laboratories

Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit

EUA 1/15/2021, revoked 1/16/2024 CE mark 5/2021   PCR
Bio-Rad Laboratories

Bio-Rad SARS-CoV-2 ddPCR Test

EUA 5/1/2020, revoked 3/27/2024     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
BioSewoon Real-Q 2019-nCoV Detection Kit EUA 7/9/2020     PCR
Boston Children's Hospital Infectious Diseases Diagnostic Laboratory (IDDL) Childrens-Altona-SARS-CoV-2 assay EUA 4/14/2020     PCR

Boston Heart Diagnostics

Boston Heart COVID-19 RT-PCR Test

EUA 7/16/2020     PCR

Boston Medical Center

BMC-CReM COVID-19 Test

EUA 7/10/2020, revoked 12/18/2021     PCR

Broad Institute Clinical Research Sequencing Platform (CRSP)

CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay Version 3

EUA 3/5/2021, revoked 7/3/2023     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 and 12/18/2020

Revoked 5/5/2022

    PCR
Bruker FluoroType SARS-CoV-2 varID Q   CE mark 6/2021   PCR

Bruker

FluoroType SARS-CoV-2/Flu/RSV panel

  CE mark 12/2020   PCR

Bruker

FluoroType SARS-CoV-2 plus

  CE mark 5/5/2020   PCR
C4Diagnostics C4Covid-19 Human   CE mark 4/2021   Isothermal amplification

Capstone Healthcare

Genus SARS-CoV-2 Assay

EUA 8/3/2020     PCR
Canary Global DigiGene COVID-19 Rapid Molecular Test Kit   CE mark 1/2022   Isothermal amplification

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

SARS-CoV-2-Assay

EUA 5/13/2020     PCR
Cellex

qSARS-CoV-2 IgG/IgM Rapid Test

EUA 4/1/2020, revoked 12/10/2021     Serological
Celltrion Celltrion DiaTrust COVID-19 Ag Home Test EUA 10/21/21, revoked 7/30/2024     Antigen
Celltrion

Celltrion DiaTrust COVID-19 Ag Rapid Test

EUA 4/16/2021, revoked 7/30/2024     Antigen
Celltrion

Sampinute COVID-19 Antigen MIA

EUA 10/23/2020, revoked 7/30/2024     Antigen
Centers for Disease Control and Prevention CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) EUA 2/4/2020, amended 3/15/2020, reissued 12/1/2020     PCR
Centers for Disease Control and Prevention

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

EUA 7/2/2020     PCR
Centogene

CentoSure SARS-CoV-2 RT-PCR Assay

EUA 9/29/2020, revoked 3/17/2022     PCR
Centogene

CentoFast SARS-CoV-2 RT-PCR test

EUA 7/1/2020, revoked 3/17/2022     PCR
Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV plus EUA 9/10/2021 CE mark 10/2021   PCR
Cepheid  Xpert Xpress CoV-2 plus EUA 5/10/2022 CE mark 5/2022   PCR
Cepheid

Xpert Xpress SARS-CoV-2 DoD

EUA 12/23/2020     PCR
Cepheid

Xpert Omni SARS-CoV-2

EUA 11/27/2020, revoked 12/20/2021     PCR
Cepheid

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

EUA 9/24/2020, revoked 4/17/2023  CE mark 11/2020   PCR
Cepheid

Xpert Xpress SARS-CoV-2 test

EUA 3/20/2020     PCR
CerTest BioTec Viasure SARS-CoV-2 Variant Real Time PCR Detection Kit   CE mark 8/2021 on BD Max system   PCR
CerTest BioTec

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

  CE mark 10/2020 on BD Max system   PCR
CerTest BioTec ViaSure 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

    Serological
Chil Chil COVID-19 Antigen Rapid Test   CE mark 10/2020   Antigen

Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory

SARS-CoV-2 RT-PCR test EUA 4/2/2020     PCR

ChromaCode

HDPCR SARS-CoV-2 real-time PCR assay EUA 6/9/2020, revoked 1/3/2023     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 SelfCheck Cobas SARS-CoV-2 Assay EUA 9/29/2021     PCR
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute SelfCheck COVID-19 TaqPath Multiplex PCR EUA 8/9/2021     PCR
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute

Cleveland Clinic SARS-CoV- Assay

EUA 8/3/2020     PCR
Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute SelfCheck Cobas SARS-CoV-2 + Flu Assay EUA 4/11/2022     PCR
Clinical Enterprise (Eurofins)

Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC

EUA 4/13/2021

    PCR
Clinical Enterprise (Eurofins)

Clinical Enterprise SARS-CoV-2 RT-PCR Assay

EUA 4/13/2021

    PCR
Clinical Enterprise (Eurofins)

EmpowerDX At-Home COVID-19 PCR Test Kit DTC

EUA 10/15/2020, reissued 2/26/2021

    Collection kit
Clinical Reference Laboratory

CRL Rapid Response

EUA 7/30/2020     Molecular
Clinomics

Clinomics TrioDx RT-PCR COVID-19 Test

EUA 2/4/2021     PCR
Co-Diagnostics Logix Smart SARS-CoV-2 DS (Direct Saliva)   CE mark 6/2021   PCR
Co-Diagnostics

Logix Smart SARS-CoV-2 Multi-Gene Test

  CE mark 11/2020   PCR
Co-Diagnostics

Logix Smart ABC Assay

  CE mark 11/2020   PCR
Co-Diagnostics

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

EUA 4/3/2020 CE mark 2/2020   PCR

Color Health

Color COVID-19 Self-Swab Collection Kit with Saline

EUA 4/14/2021     Collection kit

Color Health

Color COVID-19 Self-Swab Collection Kit DTC

EUA 3/19/2021     Collection kit

Color Health

Color COVID-19 Self-Swab Collection Kit

EUA 8/31/2020     Collection kit

Color Health

Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC

EUA 3/19/2021     Isothermal amplification

Color Health

Color SARS-CoV-2 LAMP Diagnostic Assay

EUA 5/18/2020, reissued 11/2/2021     Isothermal amplification

Columbia University Laboratory of Personalized Genomic Medicine

Triplex CII-CoV-1 rRT-PCR Test

EUA 5/12/2020     PCR
Compass Laboratory Services Compass Laboratory Services SARS-CoV2 Assay EUA 7/13/2020     PCR, Home Collection
Cormeum Laboratory Services Cormeum SARS-CoV-2 Assay EUA 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 Biomedical VitaPCR SARS-CoV2 Assay   CE mark 3/2020 Singapore Health Sciences Authority provisional authorization PCR

CSI Laboratories

CSI SARS-CoV-2 RT PCR Test

EUA 6/1/2020     PCR
CTK Biotech

OnSite COVID-19 IgG/IgM Rapid Test

EUA submission pending CE mark Q1/2020   Serological
CTK Biotech

Aridia COVID-19 PCR Test

  CE mark Q2/2020    
Cue Health

Cue COVID-19 Test for Home and Over The Counter (OTC) Use

EUA 3/5/2021, revoked 10/9/2024   Health Canada authorization 3/2022 Isothermal amplification
Cue Health

Cue COVID-19 Test

EUA 6/10/2020, revoked 10/9/2024 CE mark 2/2021   Isothermal amplification

Cuur Diagnostics

Cuur Diagnostics SARS-CoV-2 Molecular Assay

EUA 8/26/2020      PCR 
Darwin Biosciences

CoVLab

EUA submission pending     PCR
Dba SpectronRx

Hymon SARS-CoV-2 Test Kit

EUA 5/22/2020, revoked 8/23/2023     PCR
DC Department of Health Test Yourself DC At-Home COVID-19 Collection Kit EUA 4/6/2022     Home collection kit
Deep Sensing Algorithms DSA BreathPass   CE mark 2/2022   Biosensor
Detect Detect Covid-19 Test EUA 10/28/2021, revoked 4/14/2023     Isothermal amplification

Detectachem

MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit

EUA 9/1/2020     Isothermal amplification
Diabetomics CovAb SARS-CoV2 Ab Test EUA 6/4/2021     Serological
DiaCarta QuantiVirus SARS-CoV-2 Variant Detection Test   CE mark 8/2021   PCR
DiaCarta

QuantiVirus SARS-CoV-2 Multiplex Test Kit

EUA 7/21/2020     PCR
DiaCarta

QuantiVirus SARS-CoV-2 test kit

EUA 4/8/2020 CE mark 3/2020   PCR
Diagnostics Development Hub Fortitude Kit 2.0E     Singapore Health Sciences Authority provisional authorization 2/2020 PCR
Diagnostic Solutions Laboratory DSL COVID-19 Assay EUA 6/25/2020     PCR
DiaSorin Liaison SARS-CoV-2 TrimericS IgG EUA 5/19/2021     Serological
DiaSorin

Liaison SARS-CoV-2 Ag

EUA 3/26/2021 CE mark 10/2020   Antigen
DiaSorin

Diasorin Liaison SARS-CoV-2 IgM Assay

EUA 9/29/2020, revoked 3/15/2022     Serological 
DiaSorin

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 Laboratory SARS-CoV-2 PCR Test EUA 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

DnaNudge

COVID Nudge test

  CE mark 6/2020   PCR

DNA-Technology Research & Production

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

  CE mark 4/2020   PCR
Drexel University College of Medicine SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay EUA 4/19/2021, revoked 10/5/2023     PCR
DxLab DxLab COVID-19 Test EUA 6/1/2022     Isothermal amplification

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
EliTech

SARS-CoV-2 Plus ELITe MGB Assay

EUA submission pending     PCR
Ellume Ellume.lab COVID Antigen Test EUA 7/8/2021     Antigen
Emory Medical Laboratories

SARS-CoV-2 RBD IgG test

EUA 6/15/2020     Serological
Empire City Laboratories ECL COVID Test System-1 EUA 8/25/2021     PCR
Empire City Laboratories ECL COVID Test System EUA 8/25/2021     PCR
Empirical Bioscience

QuantiTase, QuantiTase Plus One Step RT-qPCR Kits

EUA submission pending     PCR
Empowered Diagnostics CovClear   CE mark Health Canada Antigen
Ender Diagnostics

Ender Lab

  CE mark 6/2020   PCR
Ender Diagnostics

Ender Mass

  CE mark 8/2020   Isothermal amplification
Enzo Biochem

Ampicollect Sample Collection Kit

EUA 4/2021     Collection device
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

ErbaLisa COVID-19 IgM ELISA

  CE mark 4/2020   Serological
Erba Mannheim

ErbaLisa COVID-19 IgG ELISA

  CE mark 4/2020   Serological
Ethos Laboratories

Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay

EUA 8/3/2020     Mass spectrometry
Eurobio Scientific EBX 042 FluCoSyn test   CE mark 9/2020   PCR
Eurobio Scientific EBX 048 Eurobioplex SARS-CoV-2 Fast-SVT test   CE mark 4/2022   PCR
Eurofins Ingenasa

Ingezim COVID 19 DR

  CE mark 6/2020   Serological
Euroimmun/PerkinElmer Anti-SARS-CoV-2 S1 Curve ELISA (IgG) EUA 10/4/2021     Serological
Euroimmun/PerkinElmer

SARS-CoV-2 Antigen ELISA

  CE mark 12/2020   Antigen
Euroimmun/PerkinElmer

EuroRealTime SARS-CoV-2/Influenza A/B

  CE mark 12/2020   PCR
Euroimmun/PerkinElmer

Anti-SARS-CoV-2 ELISA (IgG)

EUA 5/4/2020     Serological
Euroimmun/PerkinElmer

EuroRealTime SARS-CoV-2

EUA 6/8/2020 CE mark 3/2020   PCR
Euroimmun/PerkinElmer

Anti-SARS-CoV-2 ELISA (IgA)

  CE mark 3/2020   Serological
Everlywell Everlywell COVID-19 & Flu Test Home Collection Kit EUA 7/1/2021     Home collection kit

Everlywell

Everlywell COVID-19 Test Home Collection Kit DTC

EUA 2/13/2021     Home collection kit

Everlywell

Everlywell COVID-19 Test Home Collection Kit

EUA 5/15/2020     Home collection kit
Exact Sciences COVID-Flu Multiplex Assay EUA 7/1/2021, revoked 8/18/2023     PCR

Exact Sciences

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

EUA 5/22/2020, revoked 8/18/2023     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, reissued 11/19/2020     PCR

Fluidigm

Advanta Dx SARS-CoV-2 RT-PCR Assay

EUA 8/25/2020, reissued 2/26/2021. Revoked 2/1/2023

CE mark 1/2021   PCR
Fluidigm Advanta Dx COVID-19 EASE Assay EUA 2/7/2022/ Revoked 2/1/2023     PCR

Fluxergy

COVID-19 Sample-to-Answer RT-PCR test

  CE mark 3/2021   PCR
Fosun Diagnostics Novel Coronavirus Antigen Detection Kit     China National Medical Products Administration 4/2022 Antigen

Fosun Pharma USA

Fosun COVID-19 RT-PCR Detection Kit

EUA 4/17/2020     PCR
Fujifilm Europe SARS-CoV-2 Antigen   CE mark 3/2021   Antigen
Fulgent Genetics/Fulgent Therapeutics Fulgent COVID-19 by RT-PCR Test EUA 5/15/2020     PCR
Gemina Laboratories Gemina Legio X COVID-19 Rapid Antigen Test   CE mark 5/2022   Antigen
Genalyte

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

EUA 10/8/2020     Serological
Gencurix

GenePro SARS-CoV-2 Test

EUA 6/23/2020     PCR
Genomtec SARS-CoV-2 EvaGreen Direct-RT-LAMP Kit   CE mark 5/2021   Isothermal amplification
Genomtec Genomtec ID Respiratory Panel 5-Plex   CE mark 6/2022   Isothermal amplification
Gene By Gene

Gene By Gene SARS-CoV-2 Detection Test

EUA 7/7/2020     PCR
Genecast Smartrol 2019-nCoV Detection Kit v1   CE mark 6/2020 Korea Ministry of Food and Drug Safety 5/2020 PCR
Genedrive

Genedrive 96 SARS-CoV-2 Kit

EUA submission pending CE mark 5/2020   PCR
GeneFirst

GeneFirst COVID-19 Detection Kit

  CE mark 4/2020   PCR
GeneFirst

GeneFirst COVID-19 Plus Detection Kit

  CE mark 12/2020   PCR
GeneMatrix

NeoPlex COVID-19 Detection Kit

EUA 5/14/2020     PCR
GeneMe

Fast Reliable Accurate Nucleic Acid-Based Kit for COVID-19 Detection (FRANKD)

  CE mark 5/2020   Isothermal amplification
General Biologicals

GB SARS-CoV-2 Ab ELISA kit

  CE mark 8/2020   Serological
General Biologicals

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

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

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

Genetron SARS-CoV-2 RNA Test

EUA 6/5/2020 CE mark 4/2020   PCR
Genetworx

Genetworx Covid-19 Nasal Swab Test

EUA 12/15/2020     PCR
GenMark Diagnostics

ePlex Respiratory Pathogen Panel 2 (RP2)

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

ePlex SARS-CoV-2 Test (discontinued)

EUA 3/19/2020     PCR
GenMark Diagnostics eSensor SARS-CoV-2 test EUA submission pending     PCR
Genomica/PharmMar Group 2 kits: qCOVID-19, CLART COVID-19   CE mark 3/2020   PCR

GenScript Biotech

cPass SARS-CoV-2 Neutralization Antibody Detection Kit

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

GenoSensor

GS COVID-19 RT-PCR Kit

EUA 4/16/2020     PCR

George Washington University Public Healt Laboratory

GWU COVID-19 RT-PCR Test

EUA 8/7/2020     PCR

GetMyDNA

GetMyDNA COVID-19 Test Home Collection Kit

EUA 3/9/2021     Home collection kit

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

Gnomegen COVID-19-RT-qPCR Detection Kit

EUA 5/8/2020     PCR

Gnomegen

Gnomegen COVID-19 RT-Digital PCR Detection Kit

EUA 4/6/2020     PCR
Gold Standard Diagnostics/Eurofins Technologies GSD NovaType II SARS-CoV-2   CE mark 4/2021   PCR
Gold Standard Diagnostics/Eurofins Technologies

GSD NovaGen SARS-CoV-2 (COVID-19) antigen rapid test

  CE mark 12/2020   Antigen
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 SARS-CoV-2 RT-PCR for use with DTC kits

EUA 2/13/2021     PCR

Gravity Diagnostics

Gravity Diagnostics SARS-CoV-2 RT-PCR Assay

EUA 11/23/2020     PCR

Gravity Diagnostics

Gravity Diagnostics COVID-19 Assay   

EUA 6/1/2020,

revoked 7/21/2021

    PCR

Grifols Diagnostic Solutions

Procleix SARS-CoV-2 Assay

EUA 2/10/2021, revoked 8/15/2024 CE mark 5/2020   Isothermal amplification

Guardant Health

Guardant-19

EUA 8/21/2020

revoked 8/6/2021

    Sequencing
HA Tech

SARS-CoV-2 RT-PCR Multiplex Diagnostic Kit

  CE mark 3/2021   PCR

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 pending CE mark 2/2020   Serological
Hangzhou Biotest Biotech

RightSign COVID-19 IgG/IgM Rapid Test Cassette

EUA 6/4/2020     Serological
Harvard University Clinical Laboratory (HUCL) Quaeris SARS-CoV-2 Assay EUA 5/21/2021     PCR
Hayat Genetics

Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit

  CE mark 9/2020   Isothermal amplification
Healgen Scientific

2019-nCoV Direct qPCR Kit

  CE mark 4/2020   PCR
Healgen Scientific COVID-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 Esoterics HealthQuest Esoterics TaqPath SARS-CoV-2 Assay EUA 6/23/2020     PCR
Helix Helix COVID-19 NGS Test

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

    Sequencing
Helix Helix COVID-19 Test EUA 7/23/2020     PCR
Helix Helix SARS-CoV-2 Test EUA 3/17/2022     PCR
Hologic Aptima SARS-CoV-2 assay with saliva sample   CE mark 7/2021   PCR
Hologic Panther Fusion SARS-CoV-2 assay EUA 3/16/2020     PCR
Hologic

Aptima SARS-CoV-2/Flu assay

EUA 12/16/2020     PCR
Hologic

Aptima SARS-CoV-2 assay

EUA 5/14/2020     PCR
iHealth Labs iHealth COVID-19 Antigen Rapid Test EUA 11/5/2021     Antigen
iHealth Labs iHealth COVID-19 Antigen Rapid Test Pro EUA 1/14/2022     Antigen
Illumina

COVIDSeq Test 

EUA 6/9/2020     Sequencing
Immundiagnostik

IDK anti-SARS-CoV-2 IgG ELISA 

   CE mark 5/2020   Serological
Immundiagnostik

MutaPLEX Coronavirus 

   CE mark 4/2020   PCR
Immunodiagnostic Systems

IDS SARS-CoV-2 IgG

EUA 2/10/2021     Serological
InBios International SCoV-2 Ag Detect Rapid Self-Test EUA 11/22/2021     Antigen
InBios International SCoV-2 Detect Neutralizing Ab ELISA EUA 10/22/2021     Serological
InBios International SCoV-2 Detect IgG Rapid Test EUA 8/24/2021     Serological
InBios International SCoV-2 Ag Detect Rapid Test EUA 5/6/2021     Antigen
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
Infusion Tech Primera COVID-19 RT-PCR Detection Kit   CE mark 5/2022   PCR

Innocreate Bioscience

Innocreate SARS-CoV-2 QD kit     Taiwan Food and Drug Administration approval PCR

Inno Diagnostics

PMSF-Inno SARS-CoV-2 RT-PCR Test

EUA 1/19/2021     PCR

Innovita (Tangshan) Biological Technology

Innovita 2019-nCoV Ab Test (Colloidal Gold)

EUA 11/23/2020     Serological
Innova Medical Group Innova SARS-CoV-2 Antigen Rapid Qualitative Test   CE mark 3/2022 UK MHRA approval Antigen
Innova Medical Group Innova SARS-CoV-2 Antigen Rapid Qualitative Self-Test   CE mark 6/2022   Antigen
Inova Diagnostics Quanta Flash SARS-CoV-2 IgG EUA 4/19/2021     Serological
InspectIR Systems InspectIR COVID-19 Breathalyzer EUA 4/14/2022     Mass spectrometry
Integrated DNA Technologies/Danaher IDT 2019-novel coronavirus kit under CDC's EUA     PCR

Integrity Laboratories

SARS-CoV-2 Assay

EUA 4/13/2020     PCR
Ipsum Diagnostics

COV-19 IDx assay

EUA 4/1/2020     PCR
iXensor

PixoTest POCT COVID-19 Antigen Test

  CE mark 6/2021   Antigen

Jiangsu Bioperfectus Technologies

COVID-19 Coronavirus Real Time PCR Kit

EUA 6/18/2020     PCR
Jiangsu Macro & Micro-Test Med-Tech SARS-CoV-2/influenza A/influenza B Nucleic Acid Combined Detection Kit   CE mark 8/2021   PCR

Jiangsu Well Biotech

Orawell IgM/IgG Rapid Test

EUA 9/23/2020     Serological

JN Medsys

ProTect Covid-19 kit

 under CDC's EUA CE mark 4/2020 Singapore Health Sciences Authority provisional authorization; Philippines FDA PCR
Kaiser Permanente Mid-Atlantic States KPMAS COVID-19 Test EUA 6/13/2020     PCR
Kantaro Biosciences

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

EUA 11/25/2020 (COVID-SeroKlir) CE mark 10/2020   Serological
Kaya 17

Kaya 17 Rapid Antigen Test

  CE mark 2/2021   Antigen
Kephera Diagnostics 

KDx SARS-CoV-2 IgG/IgM ELISA

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 7/13/2020 CE mark EUAL, Korea Centers for Disease Control and the Korea Food and Drug Administration PCR

KorvaLabs (Curative)

Curative-Korva SARS-Cov-2 Assay

EUA 4/16/2020

revoked 7/15/2021

    PCR

Kroger Health

Kroger Health COVID-19 Test Home Collection Kit

EUA 6/30/2020     Home collection kit
Kwokman Diagnostics Kwokman Diagnostics COVID-19 Home Collection Kit EUA 8/13/2021     Home collection kit
LabGenomics

LabGun COVID-19 RT-PCR Kit

EUA 4/29/2020     PCR
Laboratorio Clinico Toledo Laboratorio Clinico Toledo SARS-CoV-2 Assay EUA 7/6/2020, EUA revoked 9/21/2022     PCR
Laboratory Corporation of America Labcorp SARS-CoV-2 & Influenza A/B Assay EUA 9/30/2021     Collection kit
Laboratory Corporation of America Labcorp Seasonal Respiratory Virus RT-PCR DTC Test EUA 5/16/2022     PCR
Laboratory Corporation of America Labcorp Seasonal Respiratory Virus RT-PCR Test EUA 5/17/2022     PCR
Laboratory Corporation of America COVID-19 RT-PCR Test

EUA 3/16/2020, reissued 4/20/2020, 7/24/2020, 9/18/2020, 12/9/2020

    PCR
Laboratory Corporation of America Labcorp VirSeq SARS-CoV-2 NGS Test EUA 6/10/2022     Sequencing
LetsGetChecked (PrivaPath Diagnostics)

LetsGetChecked Coronavirus (COVID-19) Test

EUA 5/28/2020     PCR
LGC, Biosearch Technologies

Biosearch Technologies SAR-CoV-2 Real-Time and End-Point RT-PCR Test

EUA 4/15/2021, revoked 6/1/2023     PCR
LGC, Biosearch Technologies

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

under CDC's EUA     PCR
LGC, Biosearch Technologies Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test EUA 4/26/2022, revoked 6/1/2023     PCR
LG Chem AdvanSure SARS-CoV-2 IgG(S1) ELISA EUA 5/19/2022     Serological
LG Chem AdvanSure SARS-CoV-2 IgG(RBD) ELISA EUA 5/31/2022     Serological
LifeHope Labs

LifeHope2019-nCoV Real-Time RT-PCR Diagnostic Panel

EUA 6/29/2020, revoked 2/7/2022      PCR
Life Sciences Testing Center Life Sciences Testing Center COVID-19 Test EUA 9/22/2021     PCR
LMSI (Lighthouse Lab Services) CovidNow SARS-CoV-2 Assay EUA 10/14/2021     PCR
Lucira Health

Lucira COVID-19 Test 

EUA 4/9/2021 CE mark 5/2022 Health Canada 4/2021 LAMP
Lucira Health

Lucira COVID-19 All-In-One Test Kit

EUA 11/17/2020     LAMP
Lucira Health Lucira COVID-19 & Flu Test   CE mark 5/2022   LAMP
Luminex

NxTAG RPP + SARS-CoV-2 Assay

EUA 3/3/2021 CE mark 2/2021   PCR
Luminex

xMAP SARS-CoV-2 Multi-Antigen IgG Assay

EUA 7/16/2020, revoked 2/22/2024     Serological
Luminex

ARIES SARS-CoV-2 Assay

EUA 4/3/2020, amended 5/11/2020     PCR
Luminex Aries Flu A/B & RSV+SARS-CoV-2 Assay   CE mark 5/2022   PCR
Luminex

NxTAGCoV Extended Panel Assay

EUA 3/27/2020     PCR

Luminostics

Clip COVID Rapid Antigen Test

EUA 12/7/2020, revoked 5/5/2023     Antigen
LumiraDx SARS-CoV-2 Ag Ultra Test   CE mark 5/2022   Antigen
LumiraDx LumiraDx SARS-CoV-2 & Flu A/B Rapid Antigen Test   CE mark 12/2021   Antigen
LumiraDx LumiraDx SARS-CoV-2 Ab Test EUA 8/2/2021     Serological
LumiraDx LumiraDx SARS-CoV-2 Ag Pool Test EUA 3/2021     Antigen

LumiraDx

LumiraDx SARS-CoV-2 RNA STAR Complete

EUA 10/14/2020, revoked 8/7/2024 CE mark 6/2021   PCR

LumiraDx

LumiraDx SARS-CoV-2 Ag Test

EUA 8/18/2020     Antigen

LumiraDx

LumiraDx SARS-CoV-2 RNA STAR

EUA 8/11/2020, revoked 8/21/2024     PCR
LumiraDx Dual-Target SARS-CoV-2 STAR Complete   CE mark 6/2022   PCR
LumiraDx LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete   CE mark 6/2022   PCR
Lumivi Diagnostics SARS-CoV-2 IgG Rapid Test     Health Canada Serological

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

revoked 12/15/2022

    CRISPR 
Mammoth Biosciences DETECTR Boost SARS-CoV-2 Reagent Kit

EUA 1/21/2022

revoked 12/15/2022

    CRISPR

Massachusetts General Hospital

MGH COVID-19 qPCR assay

EUA 4/3/2020     PCR
MatMaCorp

MatMaCorp COVID-19 2SF Test

EUA 12/17/2020

revoked 8/3/2021

    PCR
Maxim Biomedical MaximBio ClearDetect COVID-19 Antigen Home Test EUA 1/19/2022     Antigen
Mayo Clinic Laboratories

SARS-CoV-2 Molecular Detection Assay

EUA 4/20/2020     PCR
Mediagnost

Anti-SARS-CoV-2 ELISA

  CE mark 5/2020   Serological
MedMira REVEALCOVID-19 Total Antibody Test EUA submission pending CE mark 5/2020   Serological
MedMira REVEALCOVID-19 Plus Total Antibody Test   CE 2/2022   Serological
Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit EUA 7/17/2020     Serological
Menarini Diagnostics CoronaMelt Var   CE mark 7/2021   PCR
Meridian Bioscience Revogene SARS-CoV-2 assay EUA 11/9/2021     PCR
Mesa Biotech Accula SARS-CoV-2 test EUA 3/23/2020, revoked 5/22/2024     PCR
MicroGem MicroGem SAL6830 SARS-CoV-2 Salive test EUA 4/14/2022     PCR

MicroGenDx (Southwest Regional PCR Laboratory)

COVID-19 Key

EUA 3/23/2020     PCR

MicrosensDx

RapiProd LAMP SARS-CoV-2 test

  CE mark 3/2021   Isothermal amplification
Minute Molecular Diagnostics DASH SARS-CoV-2/S Test EUA 3/15/2022     PCR

MiraDx

MiraDx SARS-CoV-2 RT-PCR assay 

EUA 8/31/2020     PCR

Mobidiag

Ampidiag Resp-4

  CE mark 2/2021   PCR

Mobidiag

Novodiag COVID-19

  CE mark 6/2020   PCR

Mobidiag

Amplidiag COVID-19

  CE mark 6/2020   PCR

Mologic

COVID-19 Rapid Antigen Test

  CE mark 12/2020   Antigen
Mount Sinai Hospital, Center for Clinical Laboratories Mount Sinai SARS-CoV-2 Assay EUA 8/23/2021     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 authorization Serological

Nal von Minden

Nadal COVID-19 IgG/IgM test

  CE mark 3/2020 Health Canada 3/2021 Serological
Nano-Ditech Nano-Check COVID-19 Antigen Test EUA 12/6/2021     Antigen

NanoEntek America

Frend COVID-19 Total Ab

EUA 9/29/2020     Serological
Nanomix eLab COVID-19 test   CE mark 5/2022   Antigen

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

Neomedica

Naissa SARS-CoV-2 IgM

  CE Mark 7/2020   Serological

Neomedica

Naissa SARS-CoV-2 IgG

  CE Mark 7/2020   Serological

Neomedica

Naissa SARS-CoV-2 IgA

  CE Mark 7/2020   Serological

NeuMoDx Molecular

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay

EUA 3/25/2021, revoked 5/24/2023     PCR

NeuMoDx Molecular

NeuMoDx SARS-CoV-2 Assay

EUA 3/30/2020 CE mark 5/2020   PCR
Nexus Medical Labs Nexus High Throughput SARS-CoV-2 Assay EUA 5/17/2022     PCR
New Gene (Hangzhou) Bioengineering Novel Coronavirus Spike Glycoprotein Detection Kit   CE mark 5/2020   Antigen
New Gene (Hangzhou) Bioengineering Novel Coronavirus Antigen Detection Kit   CE mark 5/2020   Antigen
New Gene (Hangzhou) Bioengineering COVID-19 IgM/IgG Antibody Detection Kit   CE mark 5/2020   Serological

NGeneBio

NGenePlex nCoV qRT-PCR kit

EUA submission pending CE mark 7/2020   PCR

Nirmidas Biotech

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

EUA 9/29/2020     Serological

Nirmidas Biotech

MidaSpot COVID-19 Antibody Combo Detection Kit

EUA 12/31/2020     Serological

Northwestern Medicine Diagnostic Molecular Laboratory

SARS-Cov-2 Assay

EUA 4/2/2020     PCR
Novacyt PathFlow COVID-19 Rapid Antigen Self-Test   CE mark 6/2022   Antigen
Novacyt ProMate COVID-19 1G (q16) Real-Time PCR test     UK CTDA 6/2022 PCR
Novacyt SNPsig VariPlex   CE mark 3/2021   PCR
Novacyt Winterplex respiratory test panel   CE mark 8/2020   PCR
Novacyt COVID-HT Direct   CE mark 2/2021

 

PCR
Novacyt/Primerdesign COVID-19 Genesig Real-Time PCR assay EUA 3/20/2020 CE mark 2/2020

EUA, India 3/26/2020

Thailand Ministry of Health, 4/2/2020

PCR
NowDiagnostics AdexusDx COVID-19 Test EUA 5/24/2021     Serological
NowDiagnostics AdexusDx 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
Oceanit Assure-100 Rapid COVID-19 Test EUA 2/28/2022     Antigen

Ohio State University Wexner Medical Center

OSUWMC COVID-19 RT-PCR test

EUA 6/17/2020     PCR

Omnipathology Solutions Medical Corporation

Omni COVID-19 Assay by RT-PCR

EUA 6/17/2020, revoked 2/14/2022     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
OnsiteGene Hi-Sense COVID-19 Molecular Testing Kit 1.0 EUA 12/19/2022     PCR

Operon

Simple/Stick Ag SARS-CoV-2

  CE mark 1/15/2021   Antigen

Operon

Real SARS-CoV-2   CE mark 12/2020   PCR

Operon

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

OpGen

SARS-CoV-2 Kit with PULB   CE mark 8/2020   PCR
Opti Medical Systems/Idexx Laboratories Opti SARS-CoV-2/Influenza A/B RT-PCR Test EUA 4/21/2022 CE mark 3/2021   PCR
Opti Medical Systems/Idexx Laboratories Opti SARS-CoV-2 Total Antibody Test   CE mark 1/2021   Serological

Opti Medical Systems/Idexx Laboratories

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

Optolane Technologies

Kaira 2019-nCoV Detection kit

EUA 9/1/2020 CE mark 4/2020   PCR
OraSure Technologies InteliSwab COVID-19 Rapid Test

EUA 6/4/2021, reissued 1/31/2022

    Antigen
OraSure Technologies InteliSwab COVID-19 Rapid Test Pro

EUA 6/4/2021, reissued 1/31/2022

    Antigen
OraSure Technologies InteliSwab COVID-19 Rapid Test Rx

EUA 6/4/2021, reissued 1/31/2022

    Antigen

Orig3n

Orig3n 2019 Novel Coronavirus (COVID-19) Test

EUA 4/10/2020     PCR
Ortho Clinical Diagnostics Vitros Anti-SARS-CoV-2 Total N Reagent Pack with Total N Antibody Calibrators EUA 7/22/2021     Serological
Ortho Clinical Diagnostics Vitros Anti-SARS-CoV-2 IgG Quantitative test EUA 7/9/2021     Serological
Ortho Clinical Diagnostics Vitros Anti-SARS-CoV-2 IgG Quantitative Antibody assay   CE mark 5/2021   Serological

Ortho Clinical Diagnostics

Vitros Anti-SARS-CoV-2 IgG 2 Antibody assay

  CE mark 3/2021   Serological

Ortho Clinical Diagnostics

Vitros Anti-SARS-CoV-2 Total 2 Antibody assay

  CE mark 3/2021   Serological

Ortho Clinical Diagnostics

Vitros SARS-CoV-2 Antigen test

EUA 1/10/2021 CE mark 10/2020, 4/2021   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, revoked 2/2/2024

CE mark 5/2020   Serological
Ortho Clinical Diagnostics

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

EUA 4/24/2020, revoked 2/2/2024

    Serological
Osang Healthcare GeneFinder COVID-19 Plus RealAmp Kit EUA 4/18/2020 CE mark 2/2020   PCR
Osang Healthcare OHC COVID-19 Antigen Self Test EUA 4/6/2022     Antigen
Oxford Nanopore Technologies

LamPore

  CE mark 10/2020   LAMP, sequencing
P23 Labs

P23 Labs TaqPath SARS-CoV-2 Assay

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

    PCR
PacificDx (ResearchDx) PacificDx Covid-19 Test EUA 12/11/2020     PCR
PathoFinder RespiFinder 2Smart kit   CE mark 11/2020   PCR
PathoFinder

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

  CE mark 11/2020   PCR
PathoFinder

RealAccurate Quadruplex Corona-plus PCR Kit

  CE mark 4/2020   PCR
PathoFinder

RealAccurate Quadruplex SARS-CoV-2 PCR Kit

  CE mark 6/2020   PCR
PathogenDx DetectX-Rv EUA 4/20/2021 CE mark 7/2021   PCR
PathogenDx DetectX-Cv+   CE mark 2/2022   PCR, microarray

Patients Choice Laboratories

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

EUA 8/28/2020      PCR 
Pelican Diagnostics

Pelican COVID-19 Ultra-Rapid Mobile Test

  CE mark 3/2021   Antigen
PerkinElmer

PerkinElmer COVID-19 Antigen Test

  CE mark 2/2021   Antigen
PerkinElmer

PKamp Respiratory SARS-CoV-2 RT-PCR Panel

EUA 10/6/2021 CE mark 10/2020   PCR
PerkinElmer

SuperFlex Anti-SARS-CoV-2 IgG kit

  CE mark 7/2020   Serological
PerkinElmer

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

  CE mark 7/2020   Serological
PerkinElmer

PerkinElmer SARS-CoV-2 RT-PCR Asssay

  CE mark 11/2020   PCR
PerkinElmer

SARS-CoV-2 RT-qPCR Reagent Kit

EUA 4/12/2021, revoked 1/30/2024 CE mark 4/2020   PCR
PerkinElmer

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

EUA 3/24/2020, reissued 10/28/2020     PCR
Phadia (Thermo Fisher Scientific)

EliA SARS-CoV-2-Sp1 IgG Test

EUA 1/11/2021     Serological
Phase Scientific International Indicaid COVID-19 Rapid Antigen Test EUA 7/28/2021     Antigen
Phase Scientific International Indicaid COVID-19 Rapid Antigen At-Home Test EUA 3/16/2022     Antigen
Phosphorus Diagnostics

Phosphorus COVID19 RT-qPCR Test DTC

EUA 5/17/2021     PCR
Phosphorus Diagnostics Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC EUA 5/17/2021     Collection kit
Phosphorus Diagnostics

Phosphorus COVID-19 RT-qPCR Test

EUA 6/4/2020, reissued 12/15/2020     PCR
Pictor PictArray SARS-CoV-2 IgG   CE mark 6/2022   Serological
PlexBio

IntelliPlex SARS-CoV-2 Detection Kit

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

Poplar SARS-CoV-2 TMA Pooling assay

EUA 8/3/2020     Isothermal amplification
PreciGenome

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

EUA 6/25/2020     PCR
Precision Biosensor Exdia COVID-19 IgG/IgM  

CE mark 6/2020

  Serology
Precision Biosensor Exdia COVID-19 Ag   CE mark 9/2020

Korea Ministry of Food and Drug Safety 8/2021

FDA Thailand 4/2021

Antigen
Precision Biosensor PBCheck COVID-19 IgG/IgM   CE mark 6/2020   Serology
Precision Biosensor PBCheck COVID-19 Ag   CE mark 10/2020

Korea Ministry of Food and Drug Safety 8/2021

Philippines FDA 1/2022

Roszdravnadzor (Russian Federation) 4/2021

Antigen
Premier Medical Laboratory Services PMLS SARS-CoV-2 Assay EUA 1/7/2022     PCR
Prenetics Circle HealthPod   CE mark 7/2021   PCR

Princeton BioMeditech

Status COVID-19/Flu

EUA 2/4/2021     Antigen

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
Promega Lumit Dx SARS-CoV-2 Immunoassay   CE mark 6/2021   Serological
ProterixBio SARS-CoV-2 (RBD) IgG Antibody test EUA submission pending     Serological
Psomagen Psoma COVID-19 RT Test EUA 6/30/2020     PCR
QDx Pathology Services QDX SARS-CoV-2 Assay EUA 8/25/2020     PCR
Qiagen Qiareach SARS-CoV-2 Antigen Test EUA 8/2021     Antigen
Qiagen Qiareach Anti-SARS-CoV-2 Total Test EUA 5/11/2021     Serological
Qiagen

Artus SARS-CoV-2 Prep&Amp UM Kit

  CE mark 4/2021   PCR
Qiagen QiaStat-Dx Respiratory SARS-CoV-2 Panel EUA 3/30/2020 CE mark 3/2020   PCR
Qlife Aps Egoo SARS-CoV-2 POC test   CE mark 1/2021   Isothermal amplification
Qorvo Biotechnologies

Omnia SARS-CoV-2 Antigen Test

EUA 4/13/2021     Antigen
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
Quanterix

Simoa SARS-CoV-2 N Protein Antigen Test

EUA 1/5/2021, revoked 5/10/2022     Antigen
Quanterix Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test EUA 12/23/2020, revoked 5/10/2022     Serological
QuantuMDx Q-POC SARS-CoV-2, Flu A/B & RSV Assay   CE mark 5/2022   PCR
QuantuMDx SARS-CoV-2 RT-PCR Detection Assay   CE mark 6/2020   PCR
Quest Diagnostics Infectious Disease Quest Diagnostics Collection Kit for COVID-19 EUA 10/8/2021     Collection kit
Quest Diagnostics Infectious Disease

Quest Diagnostics RC COVID-19 +Flu RT-PCR

EUA 12/4/2020     PCR
Quest Diagnostics Infectious Disease Quest Diagnostics HA SARS-CoV-2 EUA 7/15/2020     PCR
Quest Diagnostics Infectious Disease Quest Diagnostics RC SARS-CoV-2 Assay

EUA 7/15/2020, reissued 11/27/2020

    PCR
Quest Diagnostics Infectious Disease Quest Diagnostics PF SARS-CoV-2 Assay EUA 7/15/2020     PCR
Quest Diagnostics Coronavirus Disease 2019 (COVID-19) Test EUA 3/17/2020, reissued 7/18/2020     PCR
Quest Diagnostics Nichols Institute Quest COVID-19 PCR DTC EUA 3/21/2022     PCR
Quest Diagnostics Nichols Institute Quest PF COVID-19 PCR DTC EUA 3/21/2022      PCR
Quest Diagnostics Nichols Institute Quest RC COVID-19 PCR DTC EUA 3/21/2022     PCR
Quest Diagnostics Nichols Institute Quest COVID-19 PCR Test Home Collection Kit EUA 3/21/2022     Collection kit
Quidel

QuickVue At-Home OTC COVID-19 Test

EUA 3/31/2021     Antigen
Quidel

QuickVue At-Home COVID-19 Test

EUA 3/1/2021     Antigen
Quidel

Solana SARS-CoV-2 Assay

EUA 12/23/2020     Isothermal amplification
Quidel

QuickVue SARS Antigen test

EUA 12/18/2020     Antigen
Quidel

Sofia 2 Flu + SARS Antigen FIA

EUA 10/2/2020     Antigen
Quidel Sofia 2 SARS Antigen FIA EUA 5/8/2020 CE mark 7/2020   Antigen
Quidel Lyra SARS-CoV-2 Assay EUA 3/17/2020, amended 3/23/2020 CE mark 3/2020   PCR

Quidel

Lyra Direct SARS-CoV-2 Assay

EUA 5/18/2020 CE mark 5/2020   PCR

Quotient Limited/Quotient Suisse

MosaiQ COVID-19 Antibody Magazine

EUA 9/25/2020, revoked 1/11/2022  CE mark 5/2020   Serological

RapidRona

RapidRona Self-Collection Kit

EUA 11/23/2020     Collection Kit

R-Biopharm

Rida Gene SARS-CoV-2

  CE mark 5/2020   PCR

Rendu Biotechnology

2019-nCoV detection kit

    China NMPA 3/2020 Isothermal amplification
Rheonix Rheonix COVID-19 MDx Assay EUA 4/29/2020     PCR
Roche Cobas SARS-CoV-2 Nucleic Acid Test (for Cobas Liat system) EUA 6/17/2021, revoked 8/5/2024     PCR
Roche SARS-CoV-2 Antigen Self Test Nasal   CE mark 6/2021   Antigen
Roche

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

EUA 9/14/2020, revoked 7/3/2024     PCR
Roche

Cobas SARS-CoV-2 & Influenza A/B

EUA 9/3/2020     PCR
Roche

Elecsys Anti-SARS-CoV-2 S

EUA 11/25/2020     Serological
Roche

Elecsys Anti-SARS-CoV-2

EUA 5/2/2020     Serological
Roche Cobas SARS-CoV-2 Test

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

CE mark 2020   PCR
Roche Cobas SARS-CoV-2 Duo EUA 6/14/2022     PCR

RTA Laboratories

Diagnovital SARS-CoV-2 Real-Time PCR Kit

EUA 6/12/2020, revoked 3/14/2022     PCR

Rutgers University Clinical Genomics Laboratory

ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit

EUA 4/10/2020, amended 5/7/2020     PCR
Sacace Biotechnologies SARS-CoV-2 Real-TM   CE mark 4/2020   PCR
Salofa Sienna-Clarity COVID-19 Antigen Rapid Test Cassette EUA 5/20/2021     Antigen

Salofa

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, revoked 6/7/2022     PCR
Scope Fluidics/Curiosity Diagnostics PCR One SARS-CoV-2 panel   CE mark 7/2021   PCR
SD Biosensor/Roche COVID-19 At-Home Test EUA 12/24/2021     Antigen
SD Biosensor/Roche

SARS-CoV-2 Rapid Antigen Test Nasal

  CE mark 2/2021   Antigen
SD Biosensor/Roche

SARS-CoV-2 Rapid Antigen Test

  CE mark 9/2020   Antigen
SD Biosensor

Standard M nCoV Real-Time Detection Kit

EUA 4/23/2020     PCR
SD Biosensor

Standard Q COVID-19 IgM/IgG Duo Test

      Serological
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
Seegene Combo Swab   CE mark 8/2021   Collection swab
Seegene

Allplex SARS-CoV-2/FluA/FluB/RSV Assay

  CE mark 9/2020   PCR
Seegene Allplex 2019-nCoV Assay EUA 4/21/2020 CE mark 2/2020 EUA, Korea Ministry of Food and Drug Safety PCR
Seegene Allplex SARS-CoV-2 fast MDx Assay   CE mark 2/2022   Isothermal amplification
Seegene Allplex RV Master Assay   CE mark 4/2022 Australian Register of Therapeutic Goods approval PCR
Sense Biodetection Veros COVID-19   CE mark 3/2022   Isothermal amplification

Sentinel Diagnostics

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

SeqOnce Biosciences

AzureSeq SARS-CoV-2 RT-qPCR Kit EUA submission pending     PCR
SG Diagnostics COVID-19 IgG/IgM Rapid Test Kit   CE mark 12/2020   Serological
SG Diagnostics COVID-19 Triplex RT-qPCR Detection Kit     CE mark 12/2020   PCR
SG Diagnostics Influenza A/B + COVID-19 Rapid Test Kit   CE mark 12/2020   Antigen
SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Nucleocapsid Protein IgG)    CE mark 2/2021   Serological
SG Diagnostics COVID-19 ELISA Test   CE mark 2/2021   Serological
SG Diagnostics COVID-19 Immunity Strength Semi-Quantitative Detection Kit (Quantum Dot Fluorescence Immunoassay)   CE mark 7/2021   Serological
SG Diagnostics COVID-19 Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein IgG Antibody)   CE mark 7/2021   Serological
SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody)   CE mark 7/2021   Serological
SG Diagnostics COVID-19 Saliva Antigen Rapid Test Kit   CE mark 7/2021   Antigen
SG Diagnostics SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody)   CE mark 4/2021   Serological

SG Diagnostics

SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based)

  CE mark 12/2020 Singapore Health Sciences Authority 1/2021 Antigen

Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical

 

novel coronavirus nucleic acid detection kit

  CE mark 3/2020 China NMPA 3/2020 PCR

Shanghai GeneSc Biotech

LAMP Based Coronavirus 2019-nCoV Rapid Detection Kit

  CE mark 9/2020   Isothermal amplification

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
Shuwen Biotech

SARS-COV-2 RT-PCR Kit

  CE mark 1/2021   PCR
Siemens Healthineers Clinitest Rapid COVID-19 Antigen Self-Test EUA 12/29/2021     Antigen
Siemens Healthineers Advia Centaur SARS-CoV-2 IgG (sCOVG) EUA 6/17/2021     Serological
Siemens Healthineers

SARS-CoV-2 Antigen Assay (CoV2Ag)

  CE mar 2/2021   Antigen
Siemens Healthineers

Atellica IM SARS-CoV-2 IgG (sCOVG)

EUA 3/23/2021     Serological
Siemens Healthineers

Dimension EXL SARS‑CoV‑2 IgG (CV2G)

EUA 1/8/2021     Serological
Siemens Healthineers

Dimension EXL SARS‑CoV‑2 IgG (COV2G)

EUA 1/8/2021     Serological
Siemens Healthineers

SARS-CoV-2 IgG Antibody Test

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

Atellica IM SARS-CoV-2 IgG (COV2G)

EUA 7/31/2020, revoked 12/17/2021     Serological
Siemens Healthineers Atellica IM SARS-CoV-2 Antigen (CoV2Ag) EUA 3/11/2022     Antigen
Siemens Healthineers

Advia Centaur SARS-CoV-2 Total (COV2T)

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

Advia Centaur SARS-CoV-2 IgG (COV2G)

EUA 7/31/2020, revoked 12/17/2021     Serological
Siemens Healthineers Advia Centaur SARS-CoV-2 Antigen (CoV2Ag) EUA 3/11/2022     Antigen
Siemens Healthineers Dimension EXL SARS-CoV-2  EUA 6/8/2020     Serological
Siemens Healthineers Dimension Vista SARS-CoV-2  EUA 6/8/2020     Serological
Siemens Healthineers/Fast Track Diagnostics Fast Track Diagnostics (FTD) SARS-CoV-2 Assay EUA 5/5/2020, revoked 4/18/2024 CE mark 4/2020   PCR
SML Genetree

Ezplex SARS-CoV-2 G Real-Time PCR Kit

EUA 1/13/2021     PCR
Snibe Diagnostic Maglumi SARS-CoV-2 Ag   CE mar 2/2021   Antigen
Snibe Diagnostic Maglumi SARS-CoV-2 Neutralizing Antibody Assay   CE mark 1/2021   Serological
Snibe Diagnostic Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits   CE mark 2/2020   Serological
Snibe Diagnostic

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
SolGent

DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit

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

Sona Nanotech

COVID-19 rapid antigen test

EUA submission pending CE mark 12/2020   Antigen

Sorrento Therapeutics

COVI-Track Diagnostic Test

EUA submission pending     Serological
Southern California Permanente Medical Group Kaiser Permanente High Throughput SARS-CoV-2 Assay EUA 4/19/2021, revoked 9/29/2023     PCR

Specialty Diagnostic (SDI) Laboratories

SDI SARS-CoV-2 Assay

EUA 4/10/2020     PCR
Spectrum Solutions SDNA-2000, SDNA-3000 Saliva Collection Devices   CE mark 1/2021   Collection device
Spectrum Solutions SDNA-1000 Saliva Collection Device EUA 10/8/2020     Collection device
SpeeDx PlexPCR SARS-CoV-2 test   CE mark 4/2021 Australian Therapeutic Goods Administration (TGA) clearance 8/21 PCR
Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 PCR Assay

EUA 4/8/2020, reissued 11/24/2020

    PCR
Sugentech

SGTi-flex COVID-19 IgG

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

COVID-19 Self-Collected Antibody Test System

EUA 4/5/2021  

 

Serological
Synergy Diagnostic Laboratory

SynergyDx SARS-CoV-2 RNA Test

EUA 4/16/2021  

 

PCR
Synergy Diagnostic Laboratory

SynergyDx SARS-CoV-2 RNA Test DTC

EUA 4/16/2021  

 

PCR
Sysmex

HISCL SARS-CoV-2 Ag Reagent

   

Japan IVD approval for manufacturing and marketing

Antigen
Systaaq Diagnostic Products 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit   CE mark 3/2020   PCR
T2 Biosystems

T2SARS-CoV-2 Panel

EUA 8/31/2020      PCR 
Takara Bio Europe Takara SARS-CoV-2 Direct PCR detection kit   CE mark 9/2021   PCR
Talis Biomedical Talis One COVID-19 Test System EUA 11/5/2021, EUA revoked 8/23/2022     Isothermal amplification
Tangen Biosciences TangenDx SARS-CoV-2 Molecular Test EUA 9/29/2023, revoked 1/17/2024     Isothermal amplification
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 8/31/2020 CE mark 5/2020  India CDSCO 10/2020 Serological
TBG Biotechnology

ExProbe SARS-CoV-2 Testing Kit 

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

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
Therma Bright AcuVid COVID-19 Rapid Antigen Saliva Test   CE mark 4/2021   Antigen
Thermo Fisher Scientific TaqPath COVID-19 MS2 Combo Kit 2.0

EUA 8/2/2021

revoked 9/27/2021

    PCR
Thermo Fisher Scientific TaqPath COVID-19 Fast PCR Combo Kit 2.0 EUA 7/30/2021     PCR
Thermo Fisher Scientific TaqPath COVID-19 RNase P Combo Kit 2.0 EUA 7/8/2021 CE mark 9/2021   PCR
Thermo Fisher Scientific TaqPath COVID-19 Pooling Kit EUA 5/25/2021, revoked 1/16/2024     PCR
Thermo Fisher Scientific

Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit

EUA 4/9/2021     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 10/2/2020, revoked 4/13/2023 CE mark 10/2020   Serological
Thermo Fisher Scientific

Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit

EUA 2/10/2021     PCR
Thermo Fisher Scientific

Applied Biosystems TaqPath COVID–19 HT Kit

  CE mark 1/2021   PCR
Thermo Fisher Scientific

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

EUA 3/13/2020 (Combo kit), reissued 10/9/2020 CE mark 3/2020 (CE-IVD kit) Authorization in Australia, Singapore, Taiwan (Combo kit) PCR
TIB Molbiol Syntheselabor Sarbecovirus E-gene   CE mark 2/2020   PCR
Tide Laboratories DTPM COVID-19 RT-PCR EUA 6/10/2020     PCR
TNS (BioTNS) COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit EUA 6/30/2020 CE mark 5/2020   PCR
Trax Management Services Phoenix Dx 2019-CoV EUA 4/20/2020     PCR

Trax Management Services

Phoenix Dx SARS-CoV-2 Multiplex

EUA 7/13/2020     PCR

Trinity Biotech

Captia(TM) SARS-CoV-2 IgG ELISA

  CE mark 1/2021   Serological

Twist Bioscience

SARS-CoV-2 NGS Assay

EUA 3/23/2021, revoked 2/14/2023     Sequencing

UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin

SARS-CoV-2 RNA DETECTR Assay

EUA 7/9/2020     CRISPR
Uh-Oh Labs UOL COVID-19 Test EUA 2/8/2022     Isothermal amplification

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

United Biomedical

UBI SARS-CoV-2 ELISA EUA 1/15/2021     Serological

University of Alabama at Birmingham Fungal Reference Lab

FRL SARS CoV-2 Test EUA 6/23/2020     PCR

University of Arizona Genetics Core for Clinical Services

COVID-19 ELISA pan-Ig Antibody Test 

EUA 8/31/2020

revoked 12/16/2022

    Serological

University of California, Los Angeles

UCLA SwabSeq COVID-19 Diagnostic Platform

EUA 10/6/2020     PCR
University of California San Diego BCG Excite Lab UCSD Excite COVID-19 Test EUA 12/17/2021     PCR
University of California San Diego BCG Excite Lab UCSD Excite COVID-19 EL Test EUA 4/7/2022     PCR

University of California San Diego Health

UCSD RC SARS-CoV-2 Assay

EUA 7/31/2020     PCR

University of Illinois

CovidShield

EUA 2/24/2021     PCR

University of North Carolina Medical Center

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

EUA 4/10/2020     PCR

University of Pennsylvania

BD MAX COVID-19 Assay

EUA 1/19/2021     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

UTHSC/UCH SARS-CoV-2-RT-PCR Assay

EUA 5/3/2020     PCR

Vela Diagnostics

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

EUA 9/22/2020

CE mark 7/2020

  PCR

Vela Diagnostics

ViroKey SARS-CoV-2 RT-PCR Test

EUA 8/5/2020

CE mark 4/2020

Singapore Health Sciences Authority provisional authorization

PCR

Veredus Laboratories

ZeroPrep Saliva Collection Kit and extraction-free VereRT ZeroPrep COVID-19 PCR Kit

    Singapore Health Sciences Authority provisional authorization 12/2020 PCR
Veredus Laboratories

VereCoV OneMix Detection Kit

  pending Singapore Health Sciences Authority provisional authorization 10/2020 PCR, 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 6/2020 PCR

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 8/2020 PCR

Veredus Laboratories

VereCoV Detection Kit 

  CE mark 3/2020

Singapore Health Sciences Authority provisional authorization 2/2020

PCR

Verify Diagnostics

Assure Tech Ecotest COVID-19

 

  Health Canada authorization 2/2021 Serological

Verily Life Sciences

Verily COVID-19 RT-PCR Test

EUA 9/8/2020, reissued 12/18/2020, revoked 6/21/2023

    PCR

Vibrant America Clinical Labs

Vibrant COVID-19 Ab Assay EUA 6/4/2020     Serological

Viracor Eurofins

Viracor SARS-CoV-2 assay DTC EUA 2/26/2021     PCR

Viracor Eurofins

Viracor SARS-CoV-2 assay EUA 4/6/2020     PCR

Visby Medical

Visby Medical COVID-19 Point of Care Test EUA 2/8/2021     PCR

Visby Medical

Visby Medical COVID-19 EUA 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 Saliva Test Collection Kit DTC EUA 6/17/2021     Collection device
Wren Laboratories Wren Laboratories COVID-19 PCR Test DTC EUA 6/17/2021     PCR

Wren Laboratories

Wren Laboratories COVID-19 PCR Test

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

    PCR

Xiamen Biotime Biotechnology

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

EUA 7/24/2020     Serological
Xiamen Boson Biotech Rapid SARS-CoV-2 Antigen Test Card  EUA 4/6/2022     Antigen

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

XPhyto Therapeutics/3a-Diagnostics

Covid-ID Lab

  CE mark 3/2021   PCR
Xtrava Health Spera COVID-19 Ag Test EUA 10/12/2021, revoked 8/3/2023     Antigen

Yale New Haven Hospital Clinical Virology Laboratory

SARS-CoV-2 PCR test

EUA 3/31/2020     PCR
Yale School of Public Health SalivaDirect for use with DTC Kits EUA 8/27/2021     Collection device
Yale School of Public Health SalivaDirect DTC Saliva Collection Kit EUA 8/27/2021     Collection device

Yale School of Public Health

SalivaDirect At-Home Collection Kit

EUA 4/9/2021

    Collection device

Yale School of Public Health

SalivaDirect

EUA 8/15/2020, reissued 8/28/2020, reissued 12/16/2020

    PCR

YD Diagnostics

MolecuTech Real-Time COVID-19

EUA submission pending CE mark 3/2020 India 4/2020 PCR

Yourgene Health

Clarigene SARS-CoV-2   CE mark 8/2020   PCR
Zeus Scientific Zeus ELIS SARS-CoV-2 Total Antibody Test System EUA 5/11/2021     Serological

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 SafeCollect Sample Collection Kit   CE mark 8/2021   Collection device

Zymo Research

DNA/RNA Shield Collection Tube

510(k) clearance 12/14/2020     Collection device

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