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.

Coun Product Manufacturer Link

try of name /applicant
appr name
oval
Unite CDC 2019- CDC For updated information on all products listed by the FDA use this link:
d Novel https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Coronavirus framework/emergency-use-authorization#2019-ncov
s (2019-nCoV)
Real-Time
RT-PCR
Diagnostic
Panel
Unite New York Wadsworth For updated information on all products listed by the FDA use this link:
d SARS-CoV-2 Center, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Real-time NYSDOH framework/emergency-use-authorization#2019-ncov
s Reverse
Transcriptas
e (RT)-PCR
Diagnostic
Panel
Unite cobas SARS- Roche For updated information on all products listed by the FDA use this link:
d CoV-2 Molecular https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Systems, Inc. framework/emergency-use-authorization#2019-ncov
s
Unite TaqPath Thermo Fisher For updated information on all products listed by the FDA use this link:
d COVID-19 Scientific, Inc. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Combo Kit framework/emergency-use-authorization#2019-ncov
s
Unite Panther Hologic, Inc. For updated information on all products listed by the FDA use this link:
d Fusion SARS- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State CoV-2 framework/emergency-use-authorization#2019-ncov
s

1
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Unite COVID-19 Laboratory For updated information on all products listed by the FDA use this link:
d RT-PCR Test Corporation https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State of America framework/emergency-use-authorization#2019-ncov
s
Unite Lyra SARS- Quidel Corp. For updated information on all products listed by the FDA use this link:
d CoV-2 Assay https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State framework/emergency-use-authorization#2019-ncov
s
Unite Quest SARS- Quest For updated information on all products listed by the FDA use this link:
d CoV-2 rRT- Diagnostics https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State PCR Infectious framework/emergency-use-authorization#2019-ncov
s Disease, Inc.
Unite Abbott Abbott For updated information on all products listed by the FDA use this link:
d RealTime Molecular https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
s assay
Unite Simplexa DiaSorin For updated information on all products listed by the FDA use this link:
d COVID-19 Molecular LLC https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Direct framework/emergency-use-authorization#2019-ncov
s
Unite ePlex SARS- GenMark For updated information on all products listed by the FDA use this link:
d CoV-2 Test Diagnostics, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Inc. framework/emergency-use-authorization#2019-ncov
s
Unite Primerdesig Primerdesign For updated information on all products listed by the FDA use this link:
d n Ltd COVID- Ltd https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State 19 genesig framework/emergency-use-authorization#2019-ncov
s Real-Time
PCR assay
Unite Xpert Xpress (Cepheid) For updated information on all products listed by the FDA use this link:
d SARS-CoV-2 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State test framework/emergency-use-authorization#2019-ncov
s
2
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Unite BioFire BioFire For updated information on all products listed by the FDA use this link:
d COVID-19 Defense, LLC https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Test framework/emergency-use-authorization#2019-ncov
s
Unite Accula SARS- Mesa Biotech For updated information on all products listed by the FDA use this link:
d Cov-2 Test Inc. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State framework/emergency-use-authorization#2019-ncov
s
Unite PerkinElmer PerkinElmer, For updated information on all products listed by the FDA use this link:
d New Inc. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Coronavirus framework/emergency-use-authorization#2019-ncov
s Nucleic Acid
Detection
Kit
Unite AvellinoCoV Avellino Lab For updated information on all products listed by the FDA use this link:
d 2 test USA, Inc. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State framework/emergency-use-authorization#2019-ncov
s
Unite Real-Time BGI Genomics For updated information on all products listed by the FDA use this link:
d Fluorescent Co. Ltd https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State RT-PCR Kit framework/emergency-use-authorization#2019-ncov
s for
Detecting
SARS-2019-
nCoV
Unite ID NOW Abbott For updated information on all products listed by the FDA use this link:
d COVID-19 Diagnostics https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Scarborough, framework/emergency-use-authorization#2019-ncov
s Inc.

3
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Unite NxTAG CoV Luminex For updated information on all products listed by the FDA use this link:
d Extended Molecular https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Panel Assay Diagnostics, framework/emergency-use-authorization#2019-ncov
s Inc. Luminex
Molecular
Diagnostics,
Inc.
Unite NeuMoDx NeuMoDx For updated information on all products listed by the FDA use this link:
d SARS-CoV-2 Molecular, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Assay Inc. framework/emergency-use-authorization#2019-ncov
s
Unite QIAstat-Dx QIAGEN For updated information on all products listed by the FDA use this link:
d Respiratory GmbH https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
s Panel
Unite Cellex Inc. Cellex Inc. For updated information on all products listed by the FDA use this link:
d qSARS-CoV- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State 2 IgG/IgM framework/emergency-use-authorization#2019-ncov
s Rapid Test
Unite COV-19 IDx Ipsum For updated information on all products listed by the FDA use this link:
d assay Diagnostics, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State LLC framework/emergency-use-authorization#2019-ncov
s
Unite BioGX SARS- Becton, For updated information on all products listed by the FDA use this link:
d CoV-2 Dickinson & https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Reagents for Company (BD) framework/emergency-use-authorization#2019-ncov
s BD MAX
System
Unite ARIES SARS- Luminex For updated information on all products listed by the FDA use this link:
d CoV-2 Assay Corporation https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State framework/emergency-use-authorization#2019-ncov
s

4
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Unite ScienCell ScienCell For updated information on all products listed by the FDA use this link:
d SARS-CoV- Research https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State 2 Coronaviru Laboratories framework/emergency-use-authorization#2019-ncov
s s Real-time
RT-PCR (RT-
qPCR)
Detection
Kit
Unite Logix Smart Co- For updated information on all products listed by the FDA use this link:
d Coronavirus Diagnostics, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Disease Inc. framework/emergency-use-authorization#2019-ncov
s 2019
Unite Gnomegen Gnomegen For updated information on all products listed by the FDA use this link:
d COVID-19 LLC https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State RT-Digital framework/emergency-use-authorization#2019-ncov
s PCR
Detection
Kit
Unite Smart For updated information on all products listed by the FDA use this link:
d Detect InBios https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State SARS-CoV-2 International, framework/emergency-use-authorization#2019-ncov
s rRT-PCR Kit Inc.
Unite BD SARS- For updated information on all products listed by the FDA use this link:
d CoV- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State 2Reagents Becton, framework/emergency-use-authorization#2019-ncov
s for BD MAX Dickinson &
System Company
Unite For updated information on all products listed by the FDA use this link:
d QuantiVirus https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
s Test kit DiaCarta, Inc.

5
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Unite iAMP For updated information on all products listed by the FDA use this link:
d COVID-19 Atila https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
State Detection BioSystems, framework/emergency-use-authorization#2019-ncov
s Kit Inc.
Cana ROCHE cobas SARS- For updated information on all products listed by Health Canada use this link:
da (United CoV-2 https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
States) devices-authorized.html

Cana Thermo TaqPathTM For updated information on all products listed by Health Canada use this link:
da Fisher COVID-19 https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
(United Combo Kit devices-authorized.html
States)
Cana 1COPY Luminarie For updated information on all products listed by Health Canada use this link:
da COVID-19 Canada Inc. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
QPCR KIT (South Korea) devices-authorized.html
1DROP INC.
Cana ABBOTT ABBOTT For updated information on all products listed by Health Canada use this link:
da REALTIME MOLECULAR https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
SARS-COV-2 INC. (United devices-authorized.html
States)
Cana DiaPlexQ SolGent Co., For updated information on all products listed by Health Canada use this link:
da Novel Ltd https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
Coronavirus (represented devices-authorized.html
(2019-nCoV) by JK Toxpert)
Detection (South Korea)
Kit
Cana LYRA SARS- Diagnostic For updated information on all products listed by Health Canada use this link:
da COV-2 Hybrids, Inc. - https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
ASSAY Also trading devices-authorized.html
as Quidel
Corporation
(United
States)
6
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Cana NXTAG COV LUMINEX For updated information on all products listed by Health Canada use this link:
da EXTENDED MOLECULAR https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
PANEL DIAGNOSTICS, devices-authorized.html
INC.
(Canadian)
Cana SARS-CoV-2 Hologic For updated information on all products listed by Health Canada use this link:
da Assay (United https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
(Panther States) devices-authorized.html
Fusion
System)
Cana Xpert Xpress Cepheid For updated information on all products listed by Health Canada use this link:
da SARS-CoV-2 (United https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
States) devices-authorized.html

For updated information on all products listed by Health Canada use this link:
Cana Allplex https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
da 2019-NCoV devices-authorized.html
Assa Seegene Inc.
Spartan Spartan For updated information on all products listed by Health Canada use this link:
Cana Cube Bioscience https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
da CYP2C19 Inc. devices-authorized.html
System (Canada)
PerkinElmer For updated information on all products listed by Health Canada use this link:
New https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnostic-
PerkinElmer,
Cana Coronavirus devices-authorized.html
Inc. (United
da Nucleic Acid
States)
Detection
Kit
Japan Sysmex 2019-nCoV Not available
Corporation Fluorescence
Detection

7
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Real-time RT-
PCR Kit
Japan Eiken Loopamp Not available
Chemical Novel
Co., Ltd. Coronavirus
2019 (SARS-
CoV-2)
Detection Kit
Japan Roche cobas SARS- Not available
Diagnostics CoV-2
K.K.
Austr 2019-nCoV Innovita For updated information on all products listed by the TGA use this link:
alia Ab Test (Tangshan) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Colloidal Biological
Gold) Technology
Co Ltd (China)
Austr 2019-n-CoV Hangzhou For updated information on all products listed by the TGA use this link:
alia IgG/IgM Alltest Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Co Ltd (China)
Cassette
Austr Allplex™ Seegene Inc For updated information on all products listed by the TGA use this link:
alia 2019-nCoV (Korea - https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Assay Republic of)
Austr AusDiagnost AusDiagnostic For updated information on all products listed by the TGA use this link:
alia ics s Pty Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
respiratory (Australia)
virus panel
(including
SARS-CoV-2)
test
Austr Cellex Cellex Inc For updated information on all products listed by the TGA use this link:
alia qSARS-CoV- (United States https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
2 IgG/IgM Of America)
8
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Cassette
Rapid Test
kit
Austr cobas® Roche For updated information on all products listed by the TGA use this link:
alia SARS-CoV-2 Molecular https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Systems Inc
(USA)
Austr COVID-19 Zhejiang For updated information on all products listed by the TGA use this link:
alia IgG/IgM Orient Gene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Biotech Co Ltd
Cassette (China)
Austr COVID-19 Hangzhou For updated information on all products listed by the TGA use this link:
alia IgG/IgM Clongene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Biotech Co Ltd
Cassette (China)
Austr COVID-19 Hangzhou For updated information on all products listed by the TGA use this link:
alia IgG/IgM Clongene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Biotech Co Ltd
Cassette (China)
Austr COVID-19 Hangzhou For updated information on all products listed by the TGA use this link:
alia IgG/IgM Biotest https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Biotech Co Ltd
Cassette (China)
Austr COVID-19 Hangzhou For updated information on all products listed by the TGA use this link:
alia IgG/IgM Clongene https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test Biotech Co Ltd
Cassette (China)
Austr Novel Hangzhou For updated information on all products listed by the TGA use this link:
alia Coronavirus Laihe Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(2019-nCoV) Co Ltd (China)
IgM/IgG
Antibody
Combo Test
9
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Kit (Colloidal
Gold)
Austr Novel Shanghai ZJ For updated information on all products listed by the TGA use this link:
alia Coronavirus Bio-Tech Co https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(2019-nCoV) Ltd (China)
Real Time
Multiplex
RT-PCR Kit
(Detection
for 3 genes)
Austr OnSite CTK Biotech For updated information on all products listed by the TGA use this link:
alia COVID-19 Inc (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgG/IgM
Rapid Test
Austr Panther Hologic Inc For updated information on all products listed by the TGA use this link:
alia Fusion® (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
SARS-CoV-2
Assay
(Panther
Fusion®
System)
Austr SARS-CoV-2 Guangzhou For updated information on all products listed by the TGA use this link:
alia Antibody Wondfo https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Test (Lateral Biotech Co Ltd
Flow (China)
Method)
Austr SARS-CoV-2 Qingdao For updated information on all products listed by the TGA use this link:
alia IgM/lgG Hightop https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Antibody Biotech Co Ltd
Rapid Test (China)
Austr SARS-CoV-2 Qingdao For updated information on all products listed by the TGA use this link:
alia IgM/IgG Hightop https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

10
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Antibody Biotech Co Ltd

Rapid Test (China)
Austr TaqPath Life For updated information on all products listed by the TGA use this link:
alia COVID-19 Technologies https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Combo Kit Corporation
(USA)
Austr VIASURE CerTest Biotec For updated information on all products listed by the TGA use this link:
alia SARS-CoV-2 SL (Spain) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Real Time
PCR
Detection
Kit
Austr VIASURE CerTest Biotec For updated information on all products listed by the TGA use this link:
alia SARS-CoV-2 SL (Spain) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
S gene Real
Time PCR
Detection
Kit
Austr VivaDiag™ VivaChek For updated information on all products listed by the TGA use this link:
alia COVID-19 Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG (Hangzhou)
Rapid Test Co Ltd (China)
Austr VivaDiag™ VivaCheck For updated information on all products listed by the TGA use this link:
alia COVID-19 Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG (Hangzhou)
Rapid Test Co Ltd (China)
Austr VivaDiag™ VivaChek For updated information on all products listed by the TGA use this link:
alia COVID-19 Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG (Hangzhou)
Rapid Test Co Ltd (China)
Austr Wantai Beijing Wantai For updated information on all products listed by the TGA use this link:
alia SARS-CoV-2 Biologicalphar https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
macy
11
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Ab Rapid Enterprise Co
Test kit Ltd (China)
Austr Xpert® Cepheid (USA) For updated information on all products listed by the TGA use this link:
alia Xpress SARS- https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
CoV-2
Austr Novel Hangzhou For updated information on all products listed by the TGA use this link:
alia Coronavirus Laihe Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(2019-nCoV) Co Ltd (China)
IgM/IgG
Antibody
Combo Test
Kit (Colloidal
Gold)
Austr Novel Shanghai ZJ For updated information on all products listed by the TGA use this link:
alia Coronavirus Bio-Tech Co https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(2019-nCoV) Ltd (China)
Real Time
Multiplex
RT-PCR Kit
(Detection
for 3 genes)
Austr OnSite CTK Biotech For updated information on all products listed by the TGA use this link:
alia COVID-19 Inc (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgG/IgM
Rapid Test
Austr Panther Hologic Inc For updated information on all products listed by the TGA use this link:
alia Fusion® (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
SARS-CoV-2
Assay
(Panther
Fusion®
System)

12
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Austr SARS-CoV-2 Guangzhou For updated information on all products listed by the TGA use this link:
alia Antibody Wondfo https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Test (Lateral Biotech Co Ltd
Flow (China)
Method)
Austr SARS-CoV-2 Qingdao For updated information on all products listed by the TGA use this link:
alia IgM/lgG Hightop https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Antibody Biotech Co Ltd
Rapid Test (China)
Austr SARS-CoV-2 Qingdao For updated information on all products listed by the TGA use this link:
alia IgM/IgG Hightop https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Antibody Biotech Co Ltd
Rapid Test (China)
Austr TaqPath Life For updated information on all products listed by the TGA use this link:
alia COVID-19 Technologies https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Combo Kit Corporation
(USA)
Austr VIASURE CerTest Biotec For updated information on all products listed by the TGA use this link:
alia SARS-CoV-2 SL (Spain) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Real Time
PCR
Detection
Kit
Austr VIASURE CerTest Biotec For updated information on all products listed by the TGA use this link:
alia SARS-CoV-2 SL (Spain) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
S gene Real
Time PCR
Detection
Kit
Austr VivaDiag™ VivaChek For updated information on all products listed by the TGA use this link:
alia COVID-19 Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG (Hangzhou)
Rapid Test Co Ltd (China)
13
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Austr VivaDiag™ VivaCheck For updated information on all products listed by the TGA use this link:
alia COVID-19 Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG (Hangzhou)
Rapid Test Co Ltd (China)
Austr VivaDiag™ VivaChek For updated information on all products listed by the TGA use this link:
alia COVID-19 Biotech https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
IgM/IgG (Hangzhou)
Rapid Test Co Ltd (China)
Austr Wantai Beijing Wantai For updated information on all products listed by the TGA use this link:
alia SARS-CoV-2 Biologicalphar https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Ab Rapid macy
Test kit Enterprise Co
Ltd (China)
Austr Xpert® Cepheid (USA) For updated information on all products listed by the TGA use this link:
alia Xpress SARS- https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
CoV-2
Singa FORTITUDE For updated information on all products listed by the HSA use this link:
pore KIT 2.0 Diagnostics https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
Development tests-in-singapore-via-provisional-authorisation
Hub (DxD)

Singa VereCoV™ Veredus For updated information on all products listed by the HSA use this link:
pore Detection Laboratories https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
Kit Pte Ltd tests-in-singapore-via-provisional-authorisation
Singa abTES™ AITbiotech For updated information on all products listed by the HSA use this link:
pore COVID-19 Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
qPCR I Kit tests-in-singapore-via-provisional-authorisation
Singa Real-Time DSO National For updated information on all products listed by the HSA use this link:
pore PCR Assay Laboratories https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
for the tests-in-singapore-via-provisional-authorisation
Detection of
SARS-CoV-2
Virus
14
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Singa Cobas® Roche For updated information on all products listed by the HSA use this link:
pore SARS-CoV-2 Diagnostics https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
Asia Pacific tests-in-singapore-via-provisional-authorisation
Pte Ltd
Singa ProTect™ JN Medsys Pte For updated information on all products listed by the HSA use this link:
pore COVID-19 Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
RT-qPCR Kit tests-in-singapore-via-provisional-authorisation
Singa TaqPath™ Life For updated information on all products listed by the HSA use this link:
pore COVID-19 Technologies https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
Combo Kit Holdings Pte tests-in-singapore-via-provisional-authorisation
Ltd
Singa VivaDiag™ Everest Links For updated information on all products listed by the HSA use this link:
pore COVID-19 Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
IgM/IgG tests-in-singapore-via-provisional-authorisation
Rapid Test
Singa Nanjing Biolidics For updated information on all products listed by the HSA use this link:
pore Vazyme Limited https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
2019-nCoV tests-in-singapore-via-provisional-authorisation
IgG/IgM
Detection
Kit also
marketed as
Biolidics
2019-nCoV
IgG/IgM
Detection
Kit
Singa Kit for Biowalker Pte For updated information on all products listed by the HSA use this link:
pore Novel- Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
Coronavirus tests-in-singapore-via-provisional-authorisation
(2019-nCoV)
RNA
(Isothermal
15
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Amplificatio
n-Real Time
Fluorescenc
e Assay)
Singa Cepheid® SPD Scientific For updated information on all products listed by the HSA use this link:
pore Xpert® Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
Xpress SARS- tests-in-singapore-via-provisional-authorisation
CoV-2
Singa MiRXES MiRXES Pte For updated information on all products listed by the HSA use this link:
pore FORTITUDE Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
KIT 2.0 tests-in-singapore-via-provisional-authorisation
Singa Acu- Acumen For updated information on all products listed by the HSA use this link:
pore Corona™ Research https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
2.0 Laboratories tests-in-singapore-via-provisional-authorisation
Singa VitaPCR™ Credo For updated information on all products listed by the HSA use this link:
pore SARS-CoV-2 Diagnostics https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
Assay Biomedical tests-in-singapore-via-provisional-authorisation
Pte Ltd
Singa Abbott Abbott For updated information on all products listed by the HSA use this link:
pore RealTime Laboratories https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
SARS-CoV-2 (Singapore) tests-in-singapore-via-provisional-authorisation
assay Pte Ltd
Singa Seegene All Eights For updated information on all products listed by the HSA use this link:
pore AllplexTM 20 (Singapore) https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
19-nCoV Pte Ltd tests-in-singapore-via-provisional-authorisation
Assay

Singa Camtech Camtech For updated information on all products listed by the HSA use this link:
pore COVID-19 Diagnostics https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
IgM/IgG Pte Ltd tests-in-singapore-via-provisional-authorisation
Singa Acu-Corona Acumen For updated information on all products listed by the HSA use this link:
pore 3.0 Research https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostic-
tests-in-singapore-via-provisional-authorisation
16
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Laboratories
Pte Ltd
Brazil Abbott ABBOTT For updated information on all products listed by ANVISA use this link:
RealTime LABORATÓRIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
SARS-CoV-2 S DO BRASIL
EUA LTDA
Brazil COVID-19 ADVAGEN For updated information on all products listed by ANVISA use this link:
IgG/IgM LF BIOTECH LTDA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

Brazil SARS-CoV-2 BECTON For updated information on all products listed by ANVISA use this link:
S gene for DICKINSON https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
BD Max INDÚSTRIAS
CIRÚRGICAS
LTDA.
Brazil Teste BIO ADVANCE For updated information on all products listed by ANVISA use this link:
Rápido DIAGNOSTICO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
OnSite™ S LTDA
COVID-19
IgG/IgM
Brazil Kit de BIOMÉDICA For updated information on all products listed by ANVISA use this link:
Detecção EQUIPAMENT https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
por PCR em OS E
Tempo Real SUPRIMENTO
VIASURE S
SARS-CoV-2 HOSPITALARE
S LTDA
Brazil One Step CELER For updated information on all products listed by ANVISA use this link:
COVID-2019 BIOTECNOLO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Test GIA S/A
Brazil COVID-19 CEPALAB For updated information on all products listed by ANVISA use this link:
IgG/IgM LABORATÓRIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
S LTDA

17
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Brazil DPP® CHEMBIO For updated information on all products listed by ANVISA use this link:
COVID-19 DIAGNOSTICS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
IgM/IgG BRAZIL LTDA.
System
Brazil CORONAVÍR DIAGNÓSTICA For updated information on all products listed by ANVISA use this link:
US RAPID INDÚSTRIA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
TEST COMÉRCIO
LTDA
Brazil CORONAVÍR EBRAM For updated information on all products listed by ANVISA use this link:
US IgG/IgM PRODUTOS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
(COVID-19) LABORATORIA
IS LTDA
Brazil ECO F Eco For updated information on all products listed by ANVISA use this link:
COVID-19 Ag Diagnostica https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Ltda
Brazil COVID-19 Eco For updated information on all products listed by ANVISA use this link:
IgG/IgM ECO Diagnostica https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Teste Ltda
Brazil COVID-19 Ag Eco For updated information on all products listed by ANVISA use this link:
ECO Teste Diagnostica https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Ltda
Brazil Anti-SARS- EUROIMMUN For updated information on all products listed by ANVISA use this link:
CoV-2 ELISA BRASIL https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
IgA MEDICINA
DIAGNOSTICA
LTDA
Brazil Anti-SARS- EUROIMMUN For updated information on all products listed by ANVISA use this link:
CoV-2 IgG BRASIL https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
ELISA MEDICINA
DIAGNOSTICA
LTDA

18
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Brazil TR DPP® FUNDAÇÃO For updated information on all products listed by ANVISA use this link:
COVID-19 OSWALDO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
IGM/IGG - CRUZ
Bio-
Manguinhos
Brazil Kit FUNDAÇÃO For updated information on all products listed by ANVISA use this link:
MOLECULAR OSWALDO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
SARS-CoV2 CRUZ
(E/P1) - Bio-
Manguinhos
Brazil Anti COVID- LABTEST For updated information on all products listed by ANVISA use this link:
19 IgG/IgM DIAGNOSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Rapid Test S/A
Brazil LUMIRATEK LUMIRADX For updated information on all products listed by ANVISA use this link:
COVID-19 HEALTHCARE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
(IgG/IgM) LTDA
Brazil MAGLUMI MEDICAL For updated information on all products listed by ANVISA use this link:
IgM de IMPORTADOR https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
2019-nCoV AE
DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA
Brazil MAGLUMI MEDICAL For updated information on all products listed by ANVISA use this link:
IgG de 2019- IMPORTADOR https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
nCoV AE
DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA

19
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Brazil MedTeste MEDLEVENSO For updated information on all products listed by ANVISA use this link:
Coronavírus HN https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
(COVID-19) COMÉRCIO E
IgG/IgM REPRESENTAÇ
(TESTE ÕES DE
RAPIDO) PRODUTOS
HOSPITALARE
S LTDA
Brazil KIT XGEN MOBIUS LIFE For updated information on all products listed by ANVISA use this link:
MASTER SCIENCE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
COVID-19 – INDÚSTRIA E
Kit Master COMERCIO DE
para PRODUTOS
Detecção do PARA
Coronavírus LABORATÓRIO
SARS-CoV-2 S LTDA
Brazil COVID-19 QR For updated information on all products listed by ANVISA use this link:
IgG/IgM Consulting, https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Teste Importação e
Rápido ( Distribuição
Sangue de Produtos
total/ Médicos Ltda
Soro/Plasma
)
Brazil Teste QR For updated information on all products listed by ANVISA use this link:
Rápido em Consulting, https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Cassete Importação e
2019-nCoV Distribuição
IgG/IgM de Produtos
(sangue Médicos Ltda
total/soro/pl
asma

20
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

Brazil cobas® Roche For updated information on all products listed by ANVISA use this link:
SARS-CoV- Molecular https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
2 System, Inc

Brazil MAGLUMI VR MEDICAL For updated information on all products listed by ANVISA use this link:
IgG de 2019- IMPORTADOR https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
nCoV (CLIA) AE
DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA
Brazil MAGLUMI VR MEDICAL For updated information on all products listed by ANVISA use this link:
IgM de IMPORTADOR https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
2019-nCoV AE
(CLIA) DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA
Brazil Smart Test For updated information on all products listed by ANVISA use this link:
Covid-19 VYTTRA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Vyttra DIAGNOSTICO
S
IMPORTACAO
E
EXPORTACAO
S.A.

Brazil Shenzhen COVID-19 Ag For updated information on all products listed by ANVISA use this link:
Bioeasy ECO Teste https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Biotechnolo
gy Co., Ltd
21
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

S kogenebiote PowerCheckT For updated information on all products listed by the MFDS use this link:
Korea ch M2019-nCoV https://www.mfds.go.kr/eng/brd/m_52/view.do?seq=74424&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_
RT PCR kit 1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S Seegene AllplexTM201 For updated information on all products listed by the MFDS use this link:
Korea 9-nCoV Assay 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 SolGent DiaPlexQTMN For updated information on all products listed by the MFDS use this link:
Korea Co.,Ltd. Coronavirus https://www.mfds.go.kr/eng/brd/m_52/view.do?seq=74424&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_
Detection kit 1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S SD STANDARD M For updated information on all products listed by the MFDS use this link:
Korea BIOSENSOR nCoV RT https://www.mfds.go.kr/eng/brd/m_52/view.do?seq=74424&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_
Detection kit 1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S BioSewoom Real-Q 2019- For updated information on all products listed by the MFDS use this link:
Korea Inc. nCoV https://www.mfds.go.kr/eng/brd/m_52/view.do?seq=74424&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_
Detection Kit 1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

China Antibody Xiamen For updated information on all products listed by the NMPA use this link:
test kit for Innodx https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
novel Biotech Co.,
coronavirus Ltd.
2019-nCoV
(chemilumin
escence
microparticl
e
immunoassa
y)
China Antibody Guangzhou For updated information on all products listed by the NMPA use this link:
test kit for Wondfo https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
22
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

novel Biotech Co.,

coronavirus Ltd.
2019-nCoV
(colloidal
gold
method)
China Antibody INNOVITA(Tan For updated information on all products listed by the NMPA use this link:
test kit for gshan) https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
novel Biological
coronavirus Technology
2019-nCoV Co., Ltd.
(colloidal
gold
method)
China IgG Bioscience For updated information on all products listed by the NMPA use this link:
Antibody (Chongqing) https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
test kit for Diagnostic
novel Technology
coronavirus Co., Ltd.
2019-nCoV
(magnetic
particle-
based
chemilumin
escence
immunoassa
y)
China IgM Hecin For updated information on all products listed by the NMPA use this link:
antibody Scientific, Inc. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
test kit for
novel
coronavirus
2019-nCoV
23
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

(colloidal
gold
method)
China IgM Bioscience For updated information on all products listed by the NMPA use this link:
Antibody (Chongqing) https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
test kit for Diagnostic
novel Technology
coronavirus Co., Ltd.
2019-nCoV
(magnetic
particle-
based
chemilumin
escence
immunoassa
y)
China IgM/IgG Nanjing For updated information on all products listed by the NMPA use this link:
antibody Vazyme https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
test kit for Medical
novel Technology
coronavirus Co., Ltd.
2019-nCoV
(colloidal
gold
method)
China IgM/IgG Zhuhai Livzon For updated information on all products listed by the NMPA use this link:
antibody Diagnostics https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
test kit for Inc.
novel
coronavirus
2019-nCoV
(colloidal

24
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

gold
method)
China Nucleic Acid BGI For updated information on all products listed by the NMPA use this link:
reagent test Biotechnology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel (Wuhan) Co.,
coronavirus Ltd.
2019-nCoV
(combinatori
al probe-
anchor
synthesis
sequencing)
China Nucleic Acid Wuhan For updated information on all products listed by the NMPA use this link:
reagent test Zhongzhi https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Biotechnologi
coronavirus es INC.
2019-nCoV
(Dual
amplificatio
n)
China Nucleic Acid Beijing For updated information on all products listed by the NMPA use this link:
reagent test Applied https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Biological
coronavirus Technologies
2019-nCoV Co., Ltd
(fluorometri
c PCR)
China Nucleic Acid BGI For updated information on all products listed by the NMPA use this link:
reagent test Biotechnology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel (Wuhan) Co.,
coronavirus Ltd.
2019-nCoV

25
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

(fluorometri
c PCR)
China Nucleic Acid Da An Gene For updated information on all products listed by the NMPA use this link
reagent test Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
China Nucleic Acid Maccura For updated information on all products listed by the NMPA use this link:
reagent test Biotechnology
kit for novel Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus
2019-nCoV
(fluorometri
c PCR)
China Nucleic Acid Sansure For updated information on all products listed by the NMPA use this link:
reagent test Biotech Inc. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
China Nucleic Acid Shanghai For updated information on all products listed by the NMPA use this link:
reagent test BioGerm https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Medical
coronavirus Biotechnology
2019-nCoV Co., Ltd
(fluorometri
c PCR)
China Nucleic Acid Shanghai For updated information on all products listed by the NMPA use this link:
reagent test Fosun Long https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

26
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

kit for novel March

coronavirus Medical
2019-nCoV Science Co.,
(fluorometri Ltd.
c PCR)
China Nucleic Acid Shanghai For updated information on all products listed by the NMPA use this link:
reagent test GeneoDx https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Biotechnology
coronavirus Co., Ltd.
2019-nCoV
(fluorometri
c PCR)
China Nucleic Acid Shanghai ZJ For updated information on all products listed by the NMPA use this link:
reagent test Bio-Tech Co., https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Ltd.
coronavirus
2019-nCoV
(fluorometri
c PCR)
China Nucleic Acid Wuhan Easy For updated information on all products listed by the NMPA use this link:
reagent test Diagnosis https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Biomedicine
coronavirus Co., Ltd.
2019-nCoV
(fluorometri
c PCR)
China Nucleic Acid Anbio For updated information on all products listed by the NMPA use this link:
reagent test (Xiamen) https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Biotechnology
coronavirus Co., Ltd.
2019-nCoV
(hybridizatio
n capture
27
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

immunofluo
rescence)
China Nucleic Acid Ustar For updated information on all products listed by the NMPA use this link:
reagent test Biotechnologi https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel es (Hangzhou)
coronavirus Ltd.
2019-nCoV
(Isothermal
amplificatio
n-real time
fluorometric
PCR)
China Nucleic Acid Shanghai For updated information on all products listed by the NMPA use this link:
reagent test Rendu https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Biotechnology
coronavirus Co., Ltd.
2019-nCoV
(RNA
capture
probe
method)
China Nucleic Acid Wuhan For updated information on all products listed by the NMPA use this link:
reagent test Zhongzhi https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
kit for novel Biotechnologi
coronavirus es INC.
2019-nCoV
(RNA
isothermal
amplificatio
n lateral
flow assay)
China Nucleic Acid Chengdu For updated information on all products listed by the NMPA use this link:
reagent test CapitalBio https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
28
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.
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.

kit for six Biotechnology

respiratory Co., Ltd.
viruses
(constant
temperature
amplificatio
n chip)
For updated information on all products listed by Roszdravnadzor use this link:
Russi Refer to link Refer to link
https://www.roszdravnadzor.ru/services/misearch
a

29
V3 This list was compiled on 25 March and was last updated on 14 April 2020. For any updates refer to the links provided in the table.