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Coronavirus Test Tracker: Commercially Available COVID-19 Diagnostic Tests


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 Abacus Diagnostica

GenomEra SARS-CoV-2 Assay

  CE mark 7/2020   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

    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

    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 Abbott RealTime SARS-CoV-2 EUA test EUA 3/18/2020     PCR 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

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     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     PCR Amazon/SDS Lab Holdco Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test EUA 8/11/2021     PCR Amazon/SDS Lab Holdco Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 EUA 5/28/2021     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

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     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 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 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     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

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     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     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     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 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     Sequencing

Binx Health

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

EUA 10/20/2020     Collection kit

Biocan Diagnostics

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

EUA 8/25/2020     Serological 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

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 CE mark 5/2020   Serological BioMérieux Vidas anti-SARS-CoV-2 IgG test EUA 8/6/2020 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 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 RV1 Real-Time RT-PCR Kit

  CE mark 11/2020   PCR Bio-Rad Bioneer

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 BioPlex 2200 SARS-CoV-2 IgG EUA 7/1/2021     Serological Bio-Rad Laboratories

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

EUA 2/11/2021 CE mark 7/2021   PCR Bio-Rad Laboratories

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

EUA 1/15/2021 CE mark 5/2021   PCR Bio-Rad Laboratories

Bio-Rad SARS-CoV-2 ddPCR Test

EUA 5/1/2020     PCR Bio-Rad Laboratories

Platelia SARS-CoV-2 Total Ab assay

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

Novel Coronavirus COVID-19

EUA submission pending     PCR 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     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     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     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

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     Serological Celltrion

Celltrion DiaTrustCOVID-19 Ag Rapid Test

EUA 4/16/2021     Antigen Celltrion

Sampinute COVID-19 Antigen MIA

EUA 10/23/2020     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     PCR Centogene

SARS-CoV-2 RT-PCR test

EUA 7/1/2020     PCR Cepheid

Xpert Xpress SARS-CoV-2 DoD

EUA 12/23/2020     PCR Cepheid

Xpert Omni SARS-CoV-2

EUA 11/27/2020     PCR Cepheid

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

EUA 9/24/2020  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

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     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 Clevelan 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 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     Isothermal amplification Cue Health

Cue COVID-19 Test

EUA 6/10/2020 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     PCR

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     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

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 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 Eurofins Ingenasa

Ingezim COVID 19 DR

  CE mark 6/2020   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     PCR

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, reissued 11/19/2020     PCR

Fluidigm

Advanta Dx SARS-CoV-2 RT-PCR Assay

EUA 8/25/2020, reissued 2/26/2021

CE mark 1/2021   PCR

Fluxergy

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

  CE mark 3/2021   PCR

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 Fulgent Genetics/MedScan Laboratory COVID-19 EUA submission pending     Sequencing 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 Gene By Gene

Gene By Gene SARS-CoV-2 Detection Test

EUA 7/7/2020     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 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 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 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 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 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

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 Inova Diagnostics Quanta Flash SARS-CoV-2 IgG EUA 4/19/2021     Serological 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 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     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 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     PCR LGC, Biosearch Technologies

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

under CDC’s EUA     PCR LifeHope Labs

LifeHope2019-nCoV Real-Time RT-PCR Diagnostic Panel

EUA 6/29/2020     PCR Lucira Health

Lucira Check It COVID-19 Test Kit

EUA 4/9/2021   Health Canada 4/2021 LAMP Lucira Health

Lucira COVID-19 All-In-One Test Kit

EUA 11/17/2020     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     Serological Luminex

ARIES SARS-CoV-2 Assay

EUA 4/3/2020, amended 5/11/2020     PCR Luminex

NxTAGCoV Extended Panel Assay

EUA 3/27/2020     PCR

Luminostics

Clip COVID Rapid Antigen Test

EUA 12/7/2020     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 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     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     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 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 Megna Health Rapid COVID-19 IgM/IgG Combo Test Kit EUA 7/17/2020     Serological Menarini Diagnostics CoronaMelt Var   CE mark 7/2021   PCR Mesa Biotech Accula SARS-CoV-2 test EUA 3/23/2020     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

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

NanoEntek America

Frend COVID-19 Total Ab

EUA 9/29/2020     Serological

National Jewish Health

SARS-CoV-2 MassArray Test

EUA 9/29/2020     PCR and mass spectrometry

Nationwide Children’s Hospital

SARS-CoV-2 Assay

EUA 4/27/2020     PCR

Nebraska Medicine Clinical Laboratory

NEcov19 RT-PCR Assay

EUA 6/4/2020     PCR

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     PCR

NeuMoDx Molecular

NeuMoDx SARS-CoV-2 Assay

EUA 3/30/2020 CE mark 5/2020   PCR

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 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

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     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

Operon

Simple/Stick Ag SARS-CoV-2

  CE mark 15/1/2021   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   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     Antigen OraSure Technologies InteliSwab COVID-19 Rapid Test Pro EUA 6/4/2021     Antigen OraSure Technologies InteliSwab COVID-19 Rapid Test Rx EUA 6/4/2021     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

CE mark 5/2020   Serological Ortho Clinical Diagnostics

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

EUA 4/24/2020

    Serological Osang Healthcare GeneFinder COVID-19 Plus RealAmp Kit EUA 4/18/2020 CE mark 2/2020   PCR 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

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

  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  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 Scientifc International Indicaid COVID-19 Rapid Antigen Test EUA 7/28/2021     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 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 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 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     Antigen Quanterix Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test EUA 12/23/2020     Serological QuantuMDx SARS-CoV-2 RT-PCR Detection Assay EUA submission pending CE mark 6/2020   PCR 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 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 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 6/2021     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     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

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 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     PCR Scope Fluidics/Curiosity Diagnostics PCR One SARS-CoV-2 panel   CE mark 7/2021   PCR 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

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 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     Serological 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     Serological 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 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     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  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     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     PCR Thermo Fisher Scientific TaqPath COVID-19 Pooling Kit EUA 5/25/2021     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 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     Sequencing

UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin

SARS-CoV-2 RNA DETECTR Assay

EUA 7/9/2020     CRISPR

Ultimate Dx Laboratory

UDX SARS-CoV-2 Molecular Assay

EUA 4/20/2020     PCR

UMass Memorial Medical Center

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

EUA 10/1/2020     PCR

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     Serological

University of California, Los Angeles

UCLA SwabSeq COVID-19 Diagnostic Platform

EUA 10/6/2020     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

    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 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

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

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