Disclaimer: WHO does not endorse any of the lists provided ......Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist

Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links to the various lists.

1 V2 This list was compiled on 25 March and updated on 26 March 2020. For any updates refer to the links provided in the table.

Country of approval

Manufacturer/applicant name

Product name Link

United States

CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel

CDC https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

United States

New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel

Wadsworth Center, NYSDOH

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

United States

cobas SARS-CoV-2

Roche Molecular Systems, Inc.


United States

TaqPath COVID-19 Combo Kit

Thermo Fisher Scientific, Inc.


United States

Panther Fusion SARS-CoV-2

Hologic, Inc. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

United

COVID-19 RT-PCR Test

Laboratory Corporation of America
















States

United States

Lyra SARS-CoV-2 Assay

Quidel Corp. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

United States

Quest SARS-CoV-2 rRT-PCR

Quest Diagnostics Infectious Disease, Inc.


United States

Abbott RealTime SARS-CoV-2 assay

Abbott Molecular


United States

Simplexa COVID-19 Direct

DiaSorin Molecular LLC


United States

ePlex SARS-CoV-2 Test

GenMark Diagnostics, Inc.


United States

Primerdesign Ltd COVID-19 genesig Real-Time PCR assay

Primerdesign Ltd


United States

Xpert Xpress SARS-CoV-2 test

(Cepheid) https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

















United States

BioFire COVID-19 Test

BioFire Defense, LLC


United States

Accula SARS-Cov-2 Test

Mesa Biotech Inc.


Canada

ROCHE (United States)

cobas SARS-CoV-2

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19.html

Canada

Thermo Fisher (United States)

TaqPathTM COVID-19 Combo Kit


Japan No products listed yet

No products listed yet

Not available

Australia

Hangzhou Alltest Biotech Co Ltd (China)

2019-n-CoV IgG/IgM Rapid Test Cassette

https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia

AusDiagnostics Pty Ltd (Australia)

AusDiagnostics respiratory virus panel (including SARS-CoV-2) test


Australia

Roche Molecular Systems Inc (USA)

Cobas SARS-CoV-2













Australia

COVID-19 IgM, IgG, IgM/IgG rapid test

VivaCheck Biotech (Hangzhou) Co Ltd (China)


Australia

Multiple Respiratory Virus Nucleic Acid IVD Kit

Shanghai ZJ Bio-Tech Co Ltd (China)


Australia

OnSite COVID-19 IgG/IgM Rapid Test

CTK Biotech Inc (USA)


Australia

Panther Fusion SARS-CoV-2 test

Hologic Inc (USA)


Australia

SARS-CoV-2 Antibody Test (Lateral Flow Method)

Guangzhou Wondfo Biotech Co Ltd (China)


Australia

TaqPath COVID-19 Combo Kit

Life Technologies Corporation (USA)


Australia

VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit

CerTest Biotec SL (Spain)


Australia

Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)

Guangzhou Wondfo Biotech Co Ltd (China)


Australia

Xpert Xpress SARS-CoV-2

Cepheid (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia












Singapore

Diagnostics Development Hub (DxD)

The A*STAR FORTITUDE KIT 2.0

https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-tests-in-singapore-via-provisional-authorisation

Singapore

Veredus Laboratories Pte Ltd

VereCoV™ Detection Kit


Singapore

AITbiotech Pte Ltd

abTES™ COVID-19 qPCR I Kit


Singapore

DSO National Laboratories

Real-Time PCR Assay for the Detection of SARS-CoV-2 Virus


Singapore

Roche Diagnostics Asia Pacific Pte Ltd

Cobas® SARS-CoV-2


Singapore

JN Medsys Pte Ltd

ProTect™ COVID-19 RT-qPCR Kit


Singapore

Life Technologies Holdings Pte Ltd

TaqPath™ COVID-19 Combo Kit


Singapore

Everest Links Pte Ltd

VivaDiag™ COVID-19 IgM/IgG Rapid Test


Singapore

Biolidics Limited

Nanjing Vazyme 2019-






















nCoV IgG/IgM Detection Kit

Singapore

Biowalker Pte Ltd

Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)


Brazil Roche Molecular System, Inc

cobas® SARS-CoV-2

https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

Brazil CertTest Biotec S.L

RT-PCR VIASURE SARS-CoV-2

https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru

Brazil Guangzhou Wondfo Biotech Co., Ltd.

One Step COVID-2019 Test


Brazil Guangzhou Wondfo Biotech Co., Ltd.

Coronavírus Rapid Test


Brazil Hangzhou AllTest Biotech Co., Ltd

Coronavírus IgG/IgM (COVID-19)


Brazil Hangzhou AllTest Biotech

Cassete 2019-nCoV




https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus








Co., Ltd

IgG/IgM

Brazil Hangzhou AllTest Biotech Co., Ltd

MedTeste Coronavírus (COVID-19) IgG/IgM


Brazil SD Biosensor COVID-19 IgG/IgM ECO Teste


Brazil SD Biosensor ECO F COVID-19 Ag


Brazil Shenzhen Bioeasy Biotechnology Co., Ltd

COVID-19 Ag ECO Teste


S Korea

kogenebiotech PowerCheckTM2019-nCoV RT PCR kit

https://www.mfds.go.kr/eng/brd/m_52/view.do?seq=74424&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S Korea

Seegene AllplexTM2019-nCoV Assay


S Korea

SolGent Co.,Ltd.

DiaPlexQTMN Coronavirus Detection kit


S Korea

SD BIOSENSOR STANDARD M nCoV RT Detection kit


S Korea

BioSewoom Inc.

Real-Q 2019-nCoV Detection Kit


















China

Shanghai

Liferiver Bio-

Tech (United

States) Corp.

Novel

Coronavirus

2019-nCoV RT-

PCR

Kit(Fluorescen

t PCR

method）

Not available

China

Shanghai

GeneoDx

Biotech Co.,

Ltd.

Novel

Coronavirus

2019-nCoV RT-

PCR

Kit(Fluorescen

t PCR

method）

Not available

China

BGI Tech

(Wuhan) Co.,

Ltd.

Novel

Coronavirus

2019-nCoV

nucleic acid

Not available



detection kit

（cPAS,

combinatorial

probe-anchor

synthesis

sequencing

method）

China

BGI Tech

(Wuhan) Co.,

Ltd.

Novel

Coronavirus

2019-nCov

PCR Kit

(fluorescent

PCR method)

Not available

China

Da An Gene

Co., Ltd.

Novel

Coronavirus

2019-nCov

PCR Kit

Not available



(fluorescent

PCR method)

China

Sansure

Biotech

Novel

Coronavirus

2019-nCov

PCR Kit

(fluorescent

PCR method)

Not available

China

Shanghai

BioGerm

Novel

Coronavirus

2019-nCov

PCR Kit

(fluorescent

PCR method)

Not available

China Guangzhou

Wondfo

Biotech Co.,

Ltd.

Novel

Coronavirus

2019-nCov

Antibody Test

Not available



Kit (colloidal

gold method)

China

Innovita

(Tangshan)

Biotech Co.,

Ltd.

Novel

Coronavirus

2019-nCov

Antibody Test

Kit (colloidal

gold method)

Not available

China

Chengdu

Capital Biotech

Co., Ltd.

Six -

Respiratory -

Virus Nucleic

Acid Detection

Kit (isothermal

amplification

chip method)

Not available

China Beijing X-ABT

Biotech Co.,

Ltd.

Novel

Coronavirus

2019-nCov

Not available



PCR Kit

(fluorescent

PCR method)

China

Bioscience

(Chongqing)

Biotech Co.,

Ltd.

Novel

Coronavirus

（2019-

nCoV）IgM

Antibody Test

Kit（magnetic

particle

chemilumines

cence

method）

Not available

China

Bioscience

(Chongqing)

Biotech Co.,

Ltd.

Novel

Coronavirus

（2019-

nCoV）IgG

Antibody Test

Not available



Kit（magnetic

particle

chemilumines

cence

method）

China

Maccura

Biotech Co.,

Ltd.

Novel

Coronavirus

2019-nCov

PCR Kit

(fluorescent

PCR method)

Not available

China

Xiamen InnoDx

Biotech Co.,

Ltd.

Novel

Coronavirus

（2019-

nCoV）

Antibody Test

Kit（CLIA

method）

Not available



China

Guangdong

Hecin Biotech

Co., Ltd.

Novel

Coronavirus

（2019-

nCoV）IgM

Antibody Test

Kit（colloidal

gold

method）

Not available

China

Wuhan Easy

Diagnosis

Biomedicine

Co., Ltd.

Novel

Coronavirus

2019-nCov

PCR Kit

(fluorescent

PCR method)

Not available

China

Nanjing

Vazyme Biotech

Co., Ltd.

Novel

Coronavirus

（2019-

nCoV）

Not available



IgM/IgG

Antibody Test

Kit（colloidal

gold

method）

China

Zhuhai Livzon

Pharmaceutical

Group Inc.

Novel

Coronavirus

（2019-

nCoV）

IgM/IgG

Antibody Test

Kit（colloidal

gold

method）

Not available

Russi

a

Information not

available at this

time

Information

not available

at this time

https://iz.ru/988947/2020-03-19/roszdravnadzor-odobril-rossiisko-iaponskuiu-sistemu-opredeleniia-koronavirusa



Documents

Disclaimer: WHO does not endorse any of the lists provided ......Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist