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
try of
appr
oval
Unite
d
State
s

Unite
d
State
s

Unite
d
State
s
Unite
d
State
s
Unite
d
State
s

Product
name

Manufacturer
/applicant
name

Link

CDC 2019Novel
Coronavirus
(2019-nCoV)
Real-Time
RT-PCR
Diagnostic
Panel
New York
SARS-CoV-2
Real-time
Reverse
Transcriptas
e (RT)-PCR
Diagnostic
Panel
cobas SARSCoV-2

CDC

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Wadsworth
Center,
NYSDOH

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Roche
Molecular
Systems, Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

TaqPath
COVID-19
Combo Kit

Thermo Fisher
Scientific, Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Panther
Fusion SARSCoV-2

Hologic, Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

1
V3 This list was compiled on 25 March and was last updated on 7April 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
d
State
s
Unite
d
State
s
Unite
d
State
s
Unite
d
State
s
Unite
d
State
s
Unite
d
State
s
Unite
d
State
s
Unite
d
State
s

COVID-19
RT-PCR Test

Laboratory
Corporation
of America

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Lyra SARSCoV-2 Assay

Quidel Corp.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Quest SARSCoV-2 rRTPCR

Quest
Diagnostics
Infectious
Disease, Inc.
Abbott
Molecular

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

DiaSorin
Molecular LLC

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

ePlex SARSCoV-2 Test

GenMark
Diagnostics,
Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Primerdesig
n Ltd COVID19 genesig
Real-Time
PCR assay
Xpert Xpress
SARS-CoV-2
test

Primerdesign
Ltd

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

(Cepheid)

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Abbott
RealTime
SARS-CoV-2
assay
Simplexa
COVID-19
Direct

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

2
V3 This list was compiled on 25 March and was last updated on 7April 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
d
State
s

BioFire
COVID-19
Test

BioFire
Defense, LLC

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Unite
d
State
s
Unite
d
State
s

Accula SARSCov-2 Test

Mesa Biotech
Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

PerkinElmer
New
Coronavirus
Nucleic Acid
Detection
Kit
AvellinoCoV
2 test

PerkinElmer,
Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Avellino Lab
USA, Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Real-Time
Fluorescent
RT-PCR Kit
for
Detecting
SARS-2019nCoV
ID NOW
COVID-19

BGI Genomics
Co. Ltd

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Abbott
Diagnostics
Scarborough,
Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Unite
d
State
s
Unite
d
State
s

Unite
d
State
s

3
V3 This list was compiled on 25 March and was last updated on 7April 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
d
State
s

NxTAG CoV
Extended
Panel Assay

Unite
d
State
s
Unite
d
State
s
Unite
d
State
s
Unite
d
State
s
Unite
d
State
s

NeuMoDx
SARS-CoV-2
Assay

Unite
d
State
s

Luminex
Molecular
Diagnostics,
Inc. Luminex
Molecular
Diagnostics,
Inc.
NeuMoDx
Molecular,
Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

QIAstat-Dx
Respiratory
SARS-CoV-2
Panel
Cellex Inc.
qSARS-CoV2 IgG/IgM
Rapid Test
COV-19 IDx
assay

QIAGEN
GmbH

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Cellex Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Ipsum
Diagnostics,
LLC

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

BioGX SARSCoV-2
Reagents for
BD MAX
System
ARIES SARSCoV-2 Assay

Becton,
Dickinson &
Company (BD)

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Luminex
Corporation

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

4
V3 This list was compiled on 25 March and was last updated on 7April 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
d
State
s

Unite
d
State
s
Unite
d
State
s

Cana
da

Cana
da

Cana
da

Cana
da

ScienCell
SARS-CoV2 Coronaviru
s Real-time
RT-PCR (RTqPCR)
Detection
Kit
Logix Smart
Coronavirus
Disease
2019
Gnomegen
COVID-19
RT-Digital
PCR
Detection
Kit
ROCHE
(United
States)

ScienCell
Research
Laboratories

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

CoDiagnostics,
Inc.

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

Gnomegen
LLC

For updated information on all products listed by the FDA use this link:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#2019-ncov

cobas SARSCoV-2

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

Thermo
Fisher
(United
States)
1COPY
COVID-19
QPCR KIT
1DROP INC.
ABBOTT
REALTIME
SARS-COV-2

TaqPathTM
COVID-19
Combo Kit

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

Luminarie
Canada Inc.
(South Korea)

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

ABBOTT
MOLECULAR

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

5
V3 This list was compiled on 25 March and was last updated on 7April 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
da

Cana
da

DiaPlexQ
Novel
Coronavirus
(2019-nCoV)
Detection
Kit
LYRA SARSCOV-2
ASSAY

INC. (United
States)
SolGent Co.,
Ltd
(represented
by JK Toxpert)
(South Korea)

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

Diagnostic
Hybrids, Inc. Also trading
as Quidel
Corporation
(United
States)
LUMINEX
MOLECULAR
DIAGNOSTICS,
INC.
(Canadian)

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

Cana
da

NXTAG COV
EXTENDED
PANEL

Cana
da

SARS-CoV-2
Assay
(Panther
Fusion
System)
Xpert Xpress
SARS-CoV-2

Hologic
(United
States)

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

Cepheid
(United
States)

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

Sysmex
Corporation

2019-nCoV
Fluorescence
Detection

Not available

Cana
da

Japan

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/covid-19/diagnosticdevices-authorized.html

6
V3 This list was compiled on 25 March and was last updated on 7April 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.

Japan

Eiken
Chemical
Co., Ltd.

Japan

Roche
Diagnostics
K.K.
2019-nCoV
Ab Test
(Colloidal
Gold)

Austr
alia

Austr
alia

Austr
alia
Austr
alia

Austr
alia

2019-n-CoV
IgG/IgM
Rapid Test
Cassette
Allplex™
2019-nCoV
Assay
AusDiagnost
ics
respiratory
virus panel
(including
SARS-CoV-2)
test
Cellex
qSARS-CoV2 IgG/IgM

Real-time RTPCR Kit
Loopamp
Novel
Coronavirus
2019 (SARSCoV-2)
Detection Kit
cobas SARSCoV-2

Not available

Not available

Innovita
(Tangshan)
Biological
Technology
Co Ltd (China)
Hangzhou
Alltest Biotech
Co Ltd (China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Seegene Inc
(Korea Republic of)
AusDiagnostic
s Pty Ltd
(Australia)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Cellex Inc
(United States
Of America)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

7
V3 This list was compiled on 25 March and was last updated on 7April 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
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Cassette
Rapid Test
kit
cobas®
SARS-CoV-2

COVID-19
IgG/IgM
Rapid Test
Cassette
COVID-19
IgG/IgM
Rapid Test
Cassette
COVID-19
IgG/IgM
Rapid Test
Cassette
COVID-19
IgG/IgM
Rapid Test
Cassette
COVID-19
IgG/IgM
Rapid Test
Cassette
Novel
Coronavirus
(2019-nCoV)
IgM/IgG
Antibody
Combo Test

Roche
Molecular
Systems Inc
(USA)
Zhejiang
Orient Gene
Biotech Co Ltd
(China)
Hangzhou
Clongene
Biotech Co Ltd
(China)
Hangzhou
Clongene
Biotech Co Ltd
(China)
Hangzhou
Biotest
Biotech Co Ltd
(China)
Hangzhou
Clongene
Biotech Co Ltd
(China)
Hangzhou
Laihe Biotech
Co Ltd (China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

8
V3 This list was compiled on 25 March and was last updated on 7April 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
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Kit (Colloidal
Gold)
Novel
Coronavirus
(2019-nCoV)
Real Time
Multiplex
RT-PCR Kit
(Detection
for 3 genes)
OnSite
COVID-19
IgG/IgM
Rapid Test
Panther
Fusion®
SARS-CoV-2
Assay
(Panther
Fusion®
System)
SARS-CoV-2
Antibody
Test (Lateral
Flow
Method)
SARS-CoV-2
IgM/lgG
Antibody
Rapid Test
SARS-CoV-2
IgM/IgG

Shanghai ZJ
Bio-Tech Co
Ltd (China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

CTK Biotech
Inc (USA)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Hologic Inc
(USA)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Guangzhou
Wondfo
Biotech Co Ltd
(China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Qingdao
Hightop
Biotech Co Ltd
(China)
Qingdao
Hightop

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

9
V3 This list was compiled on 25 March and was last updated on 7April 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
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Antibody
Rapid Test
TaqPath
COVID-19
Combo Kit
VIASURE
SARS-CoV-2
Real Time
PCR
Detection
Kit
VIASURE
SARS-CoV-2
S gene Real
Time PCR
Detection
Kit
VivaDiag™
COVID-19
IgM/IgG
Rapid Test
VivaDiag™
COVID-19
IgM/IgG
Rapid Test
VivaDiag™
COVID-19
IgM/IgG
Rapid Test
Wantai
SARS-CoV-2

Biotech Co Ltd
(China)
Life
Technologies
Corporation
(USA)
CerTest Biotec
SL (Spain)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

CerTest Biotec
SL (Spain)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

VivaChek
Biotech
(Hangzhou)
Co Ltd (China)
VivaCheck
Biotech
(Hangzhou)
Co Ltd (China)
VivaChek
Biotech
(Hangzhou)
Co Ltd (China)
Beijing Wantai
Biologicalphar
macy

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
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 7April 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
alia
Austr
alia

Austr
alia

Austr
alia

Austr
alia

Ab Rapid
Test kit
Xpert®
Xpress SARSCoV-2
Novel
Coronavirus
(2019-nCoV)
IgM/IgG
Antibody
Combo Test
Kit (Colloidal
Gold)
Novel
Coronavirus
(2019-nCoV)
Real Time
Multiplex
RT-PCR Kit
(Detection
for 3 genes)
OnSite
COVID-19
IgG/IgM
Rapid Test
Panther
Fusion®
SARS-CoV-2
Assay
(Panther
Fusion®
System)

Enterprise Co
Ltd (China)
Cepheid (USA)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Hangzhou
Laihe Biotech
Co Ltd (China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Shanghai ZJ
Bio-Tech Co
Ltd (China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

CTK Biotech
Inc (USA)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Hologic Inc
(USA)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

11
V3 This list was compiled on 25 March and was last updated on 7April 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
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

Austr
alia

SARS-CoV-2
Antibody
Test (Lateral
Flow
Method)
SARS-CoV-2
IgM/lgG
Antibody
Rapid Test
SARS-CoV-2
IgM/IgG
Antibody
Rapid Test
TaqPath
COVID-19
Combo Kit
VIASURE
SARS-CoV-2
Real Time
PCR
Detection
Kit
VIASURE
SARS-CoV-2
S gene Real
Time PCR
Detection
Kit
VivaDiag™
COVID-19
IgM/IgG
Rapid Test

Guangzhou
Wondfo
Biotech Co Ltd
(China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Qingdao
Hightop
Biotech Co Ltd
(China)
Qingdao
Hightop
Biotech Co Ltd
(China)
Life
Technologies
Corporation
(USA)
CerTest Biotec
SL (Spain)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

CerTest Biotec
SL (Spain)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

VivaChek
Biotech
(Hangzhou)
Co Ltd (China)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

12
V3 This list was compiled on 25 March and was last updated on 7April 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
alia

Austr
alia

Austr
alia

Austr
alia
Singa
pore

Singa
pore
Singa
pore
Singa
pore

VivaDiag™
COVID-19
IgM/IgG
Rapid Test
VivaDiag™
COVID-19
IgM/IgG
Rapid Test
Wantai
SARS-CoV-2
Ab Rapid
Test kit

VivaCheck
Biotech
(Hangzhou)
Co Ltd (China)
VivaChek
Biotech
(Hangzhou)
Co Ltd (China)
Beijing Wantai
Biologicalphar
macy
Enterprise Co
Ltd (China)
Cepheid (USA)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Xpert®
Xpress SARSCoV-2
FORTITUDE
Diagnostics
KIT 2.0
Development
Hub (DxD)

For updated information on all products listed by the TGA use this link:
https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

VereCoV™
Detection
Kit
abTES™
COVID-19
qPCR I Kit
Real-Time
PCR Assay
for the
Detection of
SARS-CoV-2
Virus

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

Veredus
Laboratories
Pte Ltd
AITbiotech
Pte Ltd
DSO National
Laboratories

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

13
V3 This list was compiled on 25 March and was last updated on 7April 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
pore

Cobas®
SARS-CoV-2

Singa
pore

ProTect™
COVID-19
RT-qPCR Kit
TaqPath™
COVID-19
Combo Kit

Singa
pore

Singa
pore

Singa
pore

Singa
pore

VivaDiag™
COVID-19
IgM/IgG
Rapid Test
Nanjing
Vazyme
2019-nCoV
IgG/IgM
Detection
Kit also
marketed as
Biolidics
2019-nCoV
IgG/IgM
Detection
Kit
Kit for
NovelCoronavirus
(2019-nCoV)
RNA
(Isothermal

Roche
Diagnostics
Asia Pacific
Pte Ltd
JN Medsys Pte
Ltd
Life
Technologies
Holdings Pte
Ltd
Everest Links
Pte Ltd

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

Biolidics
Limited

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

Biowalker Pte
Ltd

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

14
V3 This list was compiled on 25 March and was last updated on 7April 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
pore

Singa
pore
Singa
pore
Singa
pore

Singa
pore

Singa
pore

Brazil

Brazil

Amplificatio
n-Real Time
Fluorescenc
e Assay)
Cepheid®
Xpert®
Xpress SARSCoV-2
MiRXES
FORTITUDE
KIT 2.0
AcuCorona™
2.0
VitaPCR™
SARS-CoV-2
Assay
Abbott
RealTime
SARS-CoV-2
assay
Seegene
AllplexTM 20
19-nCoV
Assay
Abbott
RealTime
SARS-CoV-2
EUA
COVID-19
IgG/IgM LF

SPD Scientific
Pte Ltd

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

MiRXES Pte
Ltd

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

Acumen
Research
Laboratories
Credo
Diagnostics
Biomedical
Pte Ltd
Abbott
Laboratories
(Singapore)
Pte Ltd
All Eights
(Singapore)
Pte Ltd

ABBOTT
LABORATÓRIO
S DO BRASIL
LTDA
ADVAGEN
BIOTECH LTDA

For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation
For updated information on all products listed by the HSA use this link:
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-19-diagnostictests-in-singapore-via-provisional-authorisation

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

15
V3 This list was compiled on 25 March and was last updated on 7April 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

SARS-CoV-2
S gene for
BD Max

Brazil

Teste
Rápido
OnSite™
COVID-19
IgG/IgM
Kit de
Detecção
por PCR em
Tempo Real
VIASURE
SARS-CoV-2

Brazil

Brazil

Brazil

Brazil

Brazil

One Step
COVID-2019
Test
COVID-19
IgG/IgM
DPP®
COVID-19
IgM/IgG
System
CORONAVÍR
US RAPID
TEST

BECTON
DICKINSON
INDÚSTRIAS
CIRÚRGICAS
LTDA.
BIO ADVANCE
DIAGNOSTICO
S LTDA

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

BIOMÉDICA
EQUIPAMENT
OS E
SUPRIMENTO
S
HOSPITALARE
S LTDA
CELER
BIOTECNOLO
GIA S/A
CEPALAB
LABORATÓRIO
S LTDA
CHEMBIO
DIAGNOSTICS
BRAZIL LTDA.

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

DIAGNÓSTICA
INDÚSTRIA E
COMÉRCIO
LTDA

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

16
V3 This list was compiled on 25 March and was last updated on 7April 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

CORONAVÍR
US IgG/IgM
(COVID-19)

Brazil

ECO F
COVID-19 Ag

Brazil

COVID-19
IgG/IgM ECO
Teste
COVID-19 Ag
ECO Teste

Brazil

Brazil

Anti-SARSCoV-2 ELISA
IgA

Brazil

Anti-SARSCoV-2 IgG
ELISA

Brazil

TR DPP®
COVID-19
IGM/IGG BioManguinhos
Kit
MOLECULAR
SARS-CoV2
(E/P1) - BioManguinhos

Brazil

EBRAM
PRODUTOS
LABORATORIA
IS LTDA
Eco
Diagnostica
Ltda
Eco
Diagnostica
Ltda
Eco
Diagnostica
Ltda
EUROIMMUN
BRASIL
MEDICINA
DIAGNOSTICA
LTDA
EUROIMMUN
BRASIL
MEDICINA
DIAGNOSTICA
LTDA
FUNDAÇÃO
OSWALDO
CRUZ

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru

FUNDAÇÃO
OSWALDO
CRUZ

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

17
V3 This list was compiled on 25 March and was last updated on 7April 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

Brazil

Brazil

Anti COVID19 IgG/IgM
Rapid Test
LUMIRATEK
COVID-19
(IgG/IgM)
MAGLUMI
IgM de
2019-nCoV

Brazil

MAGLUMI
IgG de 2019nCoV

Brazil

MedTeste
Coronavírus
(COVID-19)
IgG/IgM
(TESTE
RAPIDO)

Brazil

KIT XGEN
MASTER
COVID-19 –

LABTEST
DIAGNOSTICA
S/A
LUMIRADX
HEALTHCARE
LTDA
MEDICAL
IMPORTADOR
AE
DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA
MEDICAL
IMPORTADOR
AE
DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA
MEDLEVENSO
HN
COMÉRCIO E
REPRESENTAÇ
ÕES DE
PRODUTOS
HOSPITALARE
S LTDA
MOBIUS LIFE
SCIENCE
INDÚSTRIA E

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

18
V3 This list was compiled on 25 March and was last updated on 7April 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

Brazil

Brazil

Brazil

Kit Master
para
Detecção do
Coronavírus
SARS-CoV-2
COVID-19
IgG/IgM
Teste
Rápido (
Sangue
total/
Soro/Plasma
)
Teste
Rápido em
Cassete
2019-nCoV
IgG/IgM
(sangue
total/soro/pl
asma
cobas®
SARS-CoV2

COMERCIO DE
PRODUTOS
PARA
LABORATÓRIO
S LTDA
QR
For updated information on all products listed by ANVISA use this link:
Consulting,
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Importação e
Distribuição
de Produtos
Médicos Ltda

MAGLUMI
IgG de 2019nCoV (CLIA)

QR
Consulting,
Importação e
Distribuição
de Produtos
Médicos Ltda

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

Roche
Molecular
System, Inc

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

VR MEDICAL
IMPORTADOR
AE
DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

19
V3 This list was compiled on 25 March and was last updated on 7April 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

MAGLUMI
IgM de
2019-nCoV
(CLIA)

Brazil

Smart Test
Covid-19
Vyttra

Brazil

VR MEDICAL
IMPORTADOR
AE
DISTRIBUIDOR
A DE
PRODUTOS
MÉDICOS
LTDA
VYTTRA
DIAGNOSTICO
S
IMPORTACAO
E
EXPORTACAO
S.A.

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

Shenzhen
Bioeasy
Biotechnolo
gy Co., Ltd
kogenebiote
ch

COVID-19 Ag
ECO Teste

For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru

PowerCheckT
M2019-nCoV
RT PCR kit

For updated information on all products listed by the MFDS use this link:
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

AllplexTM201
9-nCoV Assay

For updated information on all products listed by the MFDS use this link:
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

SolGent
Co.,Ltd.

DiaPlexQTMN
Coronavirus
Detection kit

For updated information on all products listed by the MFDS use this link:
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

20
V3 This list was compiled on 25 March and was last updated on 7April 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
Korea

SD
BIOSENSOR

STANDARD M
nCoV RT
Detection kit

For updated information on all products listed by the MFDS use this link:
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

BioSewoom
Inc.

Real-Q 2019nCoV
Detection Kit

For updated information on all products listed by the MFDS use this link:
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

China

Antibody
test kit for
novel
coronavirus
2019-nCoV
(chemilumin
escence
microparticl
e
immunoassa
y)
Antibody
test kit for
novel
coronavirus
2019-nCoV
(colloidal
gold
method)
Antibody
test kit for
novel
coronavirus
2019-nCoV
(colloidal

Xiamen
Innodx
Biotech Co.,
Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Guangzhou
Wondfo
Biotech Co.,
Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

INNOVITA(Tan
gshan)
Biological
Technology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

China

China

21
V3 This list was compiled on 25 March and was last updated on 7April 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.

China

China

China

gold
method)
IgG
Antibody
test kit for
novel
coronavirus
2019-nCoV
(magnetic
particlebased
chemilumin
escence
immunoassa
y)
IgM
antibody
test kit for
novel
coronavirus
2019-nCoV
(colloidal
gold
method)
IgM
Antibody
test kit for
novel
coronavirus
2019-nCoV
(magnetic
particlebased

Bioscience
(Chongqing)
Diagnostic
Technology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Hecin
Scientific, Inc.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Bioscience
(Chongqing)
Diagnostic
Technology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

22
V3 This list was compiled on 25 March and was last updated on 7April 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.

China

China

China

chemilumin
escence
immunoassa
y)
IgM/IgG
antibody
test kit for
novel
coronavirus
2019-nCoV
(colloidal
gold
method)
IgM/IgG
antibody
test kit for
novel
coronavirus
2019-nCoV
(colloidal
gold
method)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(combinatori
al probeanchor
synthesis
sequencing)

Nanjing
Vazyme
Medical
Technology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Zhuhai Livzon
Diagnostics
Inc.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

BGI
Biotechnology
(Wuhan) Co.,
Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

23
V3 This list was compiled on 25 March and was last updated on 7April 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.
China

China

China

China

China

Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(Dual
amplificatio
n)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus

Wuhan
Zhongzhi
Biotechnologi
es INC.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Beijing
Applied
Biological
Technologies
Co., Ltd

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

BGI
Biotechnology
(Wuhan) Co.,
Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Da An Gene
Co., Ltd.

For updated information on all products listed by the NMPA use this link
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Maccura
Biotechnology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

24
V3 This list was compiled on 25 March and was last updated on 7April 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.

China

China

China

China

2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)

Sansure
Biotech Inc.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Shanghai
BioGerm
Medical
Biotechnology
Co., Ltd

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Shanghai
Fosun Long
March
Medical
Science Co.,
Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Shanghai
GeneoDx
Biotechnology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

25
V3 This list was compiled on 25 March and was last updated on 7April 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.
China

China

China

China

Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(fluorometri
c PCR)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(hybridizatio
n capture
immunofluo
rescence)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(Isothermal
amplificatio
n-real time
fluorometric
PCR)

Shanghai ZJ
Bio-Tech Co.,
Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Wuhan Easy
Diagnosis
Biomedicine
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Anbio
(Xiamen)
Biotechnology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Ustar
Biotechnologi
es (Hangzhou)
Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

26
V3 This list was compiled on 25 March and was last updated on 7April 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.
China

China

China

Russi
a

Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(RNA
capture
probe
method)
Nucleic Acid
reagent test
kit for novel
coronavirus
2019-nCoV
(RNA
isothermal
amplificatio
n lateral
flow assay)
Nucleic Acid
reagent test
kit for six
respiratory
viruses
(constant
temperature
amplificatio
n chip)

Shanghai
Rendu
Biotechnology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Wuhan
Zhongzhi
Biotechnologi
es INC.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Chengdu
CapitalBio
Biotechnology
Co., Ltd.

For updated information on all products listed by the NMPA use this link:
https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg

Refer to link

Refer to link

For updated information on all products listed by Roszdravnadzor use this link:
https://www.roszdravnadzor.ru/services/misearch

27
V3 This list was compiled on 25 March and was last updated on 7April 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.

28
V3 This list was compiled on 25 March and was last updated on 7April 2020. For any updates refer to the links provided in the table.