Disclaimer: This list does not reflect a decision on EUL assessment and must not be used to inform procurement

as it does not constitute an endorsement or WHO listing of the products.

R   F
information requested from follow-up amendments
manufacturer in process stage complete

Please note: these tables are updated regularly; while every attempt is made to provide current data, the most recent information might not be reflected.
This table is intended only as an update on progress and does not reflect a final decision on EUL. This table should not be used to inform
procurement.Information may not yet be reflected here.
Last update: 27 July 2021

SARS-CoV-2 Nucleic Acid Tests: progress of the active applications in the emergency use listing assessment pipeline

Manufacturer name Product name Product code(s) Dossier review QMS Desk Assessment EUL application number

Guangzhou Supbio Bio-technology and Science Co., Ltd

SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (PCR-Fluorescent
Probe)
SUPI-2501   EUL 0520-207-00

Wuhan EasyDiagnosis Biomedicine Co., Ltd. COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit nCOV-PCR-02-100B  R EUL 0523-209-00

Diagnostics for the Real World Ltd SAMBA II SARS-CoV-2 Test 8500-12   EUL 0530-072-00

Guangzhou Wondfo Biotech Co., Ltd Wondfo 2019-nCoV Real-Time RT-PCR Assay
W275P0009, W275P0010,
W275P0011 and W275P0012.   EUL 0536-004-00

KH Medical Co., Ltd RADI COVID-19 Detection Kit RV008   EUL 0538-214-00

Genedrive Diagnostics Ltd Genedrive 96 SARS-CoV2 kit

ID-CoV2-01-LPC, ID-CoV2-01-
FPC, ID-CoV2-01-BPC   EUL 0551-133-00

Seegene Inc. Allplex SARS-CoV-2 Assay RV10248X and RV10247Y   EUL 0566-225-00

Kogene Biotech Co.,Ltd PowerCheck SARS-CoV-2 Real-time PCR kit IR6902   EUL 0569-228-00

Sansure Biotech Inc

Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-
Fluorescence Probing)
S3107E24 and S3107E48   EUL 0580-201-00

Mylab Discovery Solutions Pvt Ltd. PathoDetect COVID-19 Qualitative PCR Kit PP00005   EUL 0602-236-00
SARS-CoV-2 Nucleic Acid Tests: progress of the active applications in the emergency use listing assessment pipeline
Manufacturer name Product name Product code(s) Dossier review QMS Desk Assessment EUL application number

Zybio Inc. SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) 4011601 and 4011602   EUL 0599-186-00

VS-NCO206H, VS-NCO206L,
VS-NCO212H, VS-NCO212L,
CerTest Biotec S.L. VIASURE SARS-CoV-2 Real Time PCR Detection Kit
VS-NCO213H, VS-NCO213L,
VS-NCO206HE, VS-  R EUL 0601-243-00
NCO206LE, VS-NCO212HE,
VS-NCO212LE, VS-
PCRAC0101,
Trentron Biomedical Ltd. VitaPCR SARS-CoV-2 Gen 2 assay PCRAE0120 and  R EUL 0629-252-00
PCRAE0121

Mabsky Bio.Tech Co., Ltd COVID-19 virus (2019-nCoV) Triple-Detection Kit (Real-Time PCR Method) NA   EUL 0632-253-00

Da An Gene Co., Ltd. Of Sun Yat-Sen

University
Detection Kit for 2019-nCoV (PCR-Fluorescence)
DA0990, DA0991, DA0992,
DA0993, DA0994 and DA0995   EUL 0641-141-00

Acon Biotech (Hangzhou) Co., Ltd. SARS-CoV-2 RT-PCR Test Kit P131-1591   EUL 0643-021-00

601430005,601430020,
Truenat COVID-19 Molbio Diagnostics Private Limited 601430025, 601430050,  R EUL 0647-240-00
601430100 and 601430200 .
 SARS-CoV-2 Rapid Antigen Tests: progress of the active applications in the emergency use listing assessment pipeline

Manufacturer name Product name Product code(s) Dossier review QMS Desk Assessment EUL application number

YRLF04401025,
Shenzhen Bioeasy Biotechnology Co., Ltd 2019-nCoV Ag Rapid Test Kit (Fluorescence) YRLF04401050   EUL 0572-230-00
YRLF04401100

LumiraDx UK Ltd LumiraDx SARS-CoV-2 Ag Test L0160001nnxxx   EUL 0578-234-00

Artron Laboratories Inc. Artron COVID-l9 Antigen Test  A03-50-422   EUL 0585-168-00
HGCG134A0101
Beijing Hotgen Biotech Co., Ltd Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold)
HGCG134A0105
HGCG134A0120   EUL 0591-239-00
HGCG134A0125
VivaChek Biotech (Hangzhou) Co., Ltd VivaDiag Pro SARS-CoV-2 Ag Rapid Test VCD16-01-011   EUL 0592-222-00

Xiamen Boson Biotech Co., Ltd Rapid SARS-CoV-2 Antigen Test Card 1N40C5  R EUL 0596-241-00

L031-11815
Acon Biotech (Hangzhou) Co., Ltd. SARS-CoV-2 Antigen Rapid Test L031-11825 R  EUL 0597-021-00
L031-11845

Healgen Scientific LLC Healgen Rapid COVID-19 Antigen Test GCCOV-502a  R EUL 0600-242-00

Mylab Discovery Solutions Pvt Ltd PathoCatch COVID-19 Antigen Lateral Flow Test Device AG00001   EUL 0602-236-00

Hangzhou Laihe Biotech Co., Ltd Novel Coronavirus (COVID-19) Antigen Test (Colloidal Gold) 303035   EUL 0603-226-00

Shenzhen Ultra-diagnostics Biotec

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen
Test Kit (Colloidal Gold Chromatographic Immunoassay)
SC0201, SC0202, SC0203,
and SC0204   EUL 0605-245-00

Core Technology Co.,Ltd Coretests COVID-19 Ag Test B291-22   EUL 0607-065-00

Shenzhen YHLO Biotech Co., Ltd GLINE-2019-nCoV Ag G86247   EUL 0608-224-00

CerTest Biotec S.L. CerTest SARS-CoV-2 (antigen test) SC820001PC  R EUL 0609-243-00

Jiangsu Macro & Micro Test Med Tech Co., Ltd

SARS-CoV-2 Virus Antigen Detection Kit (Immunofluorescence
Chromatography)
HWTS-RT054A   EUL 0615-248-00

Hangzhou Singclean Medical Products Co., Ltd. COVID-19 Test kit (Colloidal Gold Method)
6936020111690,
6936020111706   EUL 0622-232-00
 SARS-CoV-2 Rapid Antigen Tests: progress of the active applications in the emergency use listing assessment pipeline

Manufacturer name Product name Product code(s) Dossier review QMS Desk Assessment EUL application number

Getein Biotech Inc One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) CG2061   EUL 0625-213-00

BGI Europe A/S SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) MFG030026   EUL 0630-191-00

Hangzhou AllTest Biotech Co SARS-CoV-2 Antigen Rapid Test INCP-502-N   EUL 0631-111-00

Multibrands International Ltd Panodyne Covid-19 SARS-Cov-2 Antigen Test kit PDRTKTA-U   EUL 0635-254-00

GenesPrint Group Ltd GenesPrint Colloidal Gold Rapid Antigen Test for SARS CoV-2 COV-AG-CT awaiting submission awaiting submission EUL 0636-255-00

Innovita (Tangshan) Biological Technology

Co., Ltd.
2019-nCoV Ag Test (Latex Chromatography Assay) YF320C   EUL 0637-249-00

Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV Antigen Rapid Test Kit (Colloidal gold Assay) G11801   EUL 0639-257-00

Anhui Deepblue Medical Technology Co., Ltd COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) BSL030101   EUL 0642-258-00

Mologic Ltd COVID 19 Rapid Antigen Test 11811125 R R EUL 0644-220-00

Genbody Inc. COVID-19 Ag COVAG025   EUL 0645-259-00

Denka Co., Ltd QuickNavi-COVID-19 Ag 326294 awaiting submission awaiting submission EUL 0646-166-00

RapiGEN BIOCREDIT COVID-19 Ag

G61RHA20
and G61RHA20C   EUL 0650-160-00

Immunodiagnostics Limited COVID-19 Ag Detection Kit (Immunofluorescence-Based) 41A254 awaiting submission awaiting submission EUL 0649-260-00

Immunodiagnostics Limited COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) 41A255 awaiting submission awaiting submission EUL 0648-260-00

CTK Biotech, Inc. OnSite COVID-19 Ag Rapid Test R0182C   EUL 0653-143-00

GenSure Biotech Inc. GenSure COVID-19 Antigen Rapid Test Kit P2004 and P2004s awaiting submission awaiting submission EUL 0654-261-00

Sorrento Therapeutics Inc. COVISTIX COVID-19 VIRUS Rapid Antigen Detection Test COV-ST02 awaiting submission awaiting submission EUL 0656-262-00
SARS-CoV-2 Antibody Tests: progress of the active applications in the emergency use listing assessment pipeline

Manufacturer name Product name Product code(s) Dossier review QMS Desk Assessment EUL application number

Hangzhou AllTest Biotech Co. Ltd. 2019-nCoV IgGIgM Rapid Test Cassette (Whole BloodSerumPlasma) INCP-402B   EUL 0533-111-00

Shanghai Kehua Bioengineering Co., Ltd. Diagnostic Kit for SARS-CoV-2 IgG/IgM Antibody (Colloidal Gold)
R-423-20-C
R-423-25-C   EUL 0534-037-00

Getein Biotech Inc.

One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal
Gold)
CG2057   EUL 0537-213-00

Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) 109.01.96.02   EUL 0539-215-00

Pharmact GmbH Bel test it ! COV-2 -SARS CoV- 2 specific lgM / lgG Test Kit CV 10.01   EUL 0543-217-00

Guangzhou Wondfo Biotech Co., Ltd Wondfo 2019-nCoV Antibody Test(Lateral Flow Method) W195P0004   EUL 0546-004-00

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 Antibody Rapid Test
WJ-2710
WJ-2750   EUL 0549-005-00

Artron Laboratories Inc. COVID-l9 lgM/lgG Antibody Test A03-51-322 R  EUL 0550-168-00

Mologic Mologic COVID-19 blood IgA/IgG/IgM rapid diagnostic test 11911125   EUL 0554-220-00

VivaChek Biotech (Hangzhou) Co. Ltd VivaDiag COVID-19 IgM/IgG Rapid Test VID35-08-011   EUL 0556-222-00

RPC Diagnostic Systems, Ltd. DS-EIA-ANTI-SARS-CoV-2-G  S-2382/1.1   EUL 0558-038-00

RPC Diagnostic Systems, Ltd. DS-EIA-ANTI-SARS-CoV-2   S-2372/1.1   EUL 0557-038-00

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Wantai SARS-CoV-2 Ab ELISA WS-1096   EUL 0559-005-00

MP Biomedical Asia Pacific Pte Ltd ASSURE SARS-CoV-2 IgG/IgM Rapid Test 43140-020   EUL 0560-071-00

JOYSBIO (Tianjin) Biotechnology Co., Ltd JOYSBIO COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) G10312   EUL 0561-223-00

Shenzhen YHLO Biotech Co., Ltd iFlash-SARS-CoV-2 IgG (iFlash-2019-nCoV IgG) C86095G R  EUL 0562-224-00
SARS-CoV-2 Antibody Tests: progress of the active applications in the emergency use listing assessment pipeline
Manufacturer name Product name Product code(s) Dossier review QMS Desk Assessment EUL aplication number

Hangzhou Laihe Biotech Co., Ltd

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody ComboTest Kit (Colloidal
Gold)
303002   EUL 0567-226-00

Hangzhou Lysun Biotechnology Co., Ltd 2019-nCoV IgG/IgM Rapid Test(Colloidal Gold) COV-102   EUL 0568-227-00

Hangzhou Singclean Medical Products Co., Ltd. COVID-19 lgG/lgM Test kit (Colloidal Gold Method)
6936020111621 and
6936020111614   EUL 0575-232-00

Dynamiker Biotechnology (Tianjin) Co., Ltd 2019-nCoV IgG/IgM Rapid Test DNK-1419-1   EUL 0577-233-00

Abbott Ireland
SARS-CoV-2 IgG
(for Architect system)
06R86-02, 06R86-12, 6R86-
22, 6R86-32   EUL 0583-235-00

Maccura Biotechnology Co., Ltd.

Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG
Antibody Assay Kit by Colloidal Gold Method
BWHIM4101080 and
BWHIM4102080   EUL 0586-237-00

Bio-Rad Platelia SARS-CoV-2 Total Ab Assay 72710   EUL 0589-031-00

Premier Medical Corporation Limited Sure status Covid19 IgG/IgM card test SS02P25   EUL 0598-010-00

Institut Virion/Serion GmbH SERION ELISA agile SARS-CoV-2 IgG ESR400G   EUL 0604-244-00

11206711
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T) 11206923 awaiting submission awaiting submission EUL 0610-041-00
11206712
11206710
11206922
Siemens Healthcare Diagnostics ADVIA Centaur IM SARS-CoV-2 Total (COV2T) 11206713 awaiting submission awaiting submission EUL 0611-041-00
01137199 (112351)
03773025
11206997
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 IgG (sCOVG)
11206998
11206999   EUL 0616-041-00
10995550
11206992
11206993
11206994
Siemens Healthcare Diagnostics ADVIA Centaur® SARS-CoV-2 IgG (sCOVG 01137199 (112351)   EUL 0617-041-00
03773025
04786546

Innovita (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold) YF319C   EUL 0620-249-00

End of document.