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

Dossier QMS Desk

Product name Product code(s) Manufacturer name
review Assessment

3DMed 2019-nCoV qRT-PCR Detection Kit 3103010011 3D Biomedicine Science & Technology Co., Ltd. 1 u
SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe
Method)
1.10.11.09.nc.02 Zybio Inc. 1 u
SARS-CoV-2 Virus Detection Diagnostic Kit (RT-qPCR Method) XC25073 Ningbo Health Gene Technologies Co., Ltd. 1 u
VERI-Q PCR 316 COVID-19 Detection System 7K105 MiCo BioMed Co., Ltd. 1 u
DirectDetect SARS-COV2 Detection Kit (PCR-Fluorescence Probe) QJR Coyote Bioscience Co., Ltd 1 u
Bio-Speedy SARS-COV2 (2019-nCoV) qPCR Detection Kit BS-SY-WCOR-303-100 Bioeksen R&D Technologies Ltd. 1 R
Wantai SARS-CoV-2 RT-PCR WS-1248 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd F u
Smart Detect SARS-CoV-2 rRT-PCR Kit COV2-E InBios International, Inc. 1 1
Xpert Xpress SARS-CoV-2 XPRSARSCOV2-10 Cepheid u u
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-
Fluorescence Probing)
S3103E Sansure Biotech Inc. 1 u

COVID-19 Coronavirus Real Time PCR Kit JC10223-1NW-50T Jiangsu Bioperfectus Technologies Co.,Ltd 1 u
Fosun 2019-nCoV qPCR (Novel Coronavirus (2019-nCoV) RT-PCR
Detection Kit)
PCSYHF Shanghai Fosun Long March Medical Science Co., Ltd. F R
SARS-CoV-2 Nucleic acid detection kit based on Real-Time PCR
platform
PGA4102P2 Tellgen Corporation F u
Genskey SARS-CoV-2 RT-PCR Kit Q102 Tianjin GensKey Medical Technology Co., Ltd. R 1
SARS-CoV-2 Nucleic Acid Tests: progress of the active applications in the emergency use listing assessment pipeline
Dossier QMS Desk
Product name Product code(s) Manufacturer name
review Assessment

SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (PCR-

Fluorescent Probe)
SUPI-2501 Guangzhou Supbio Bio-technology and Science Co., Ltd 1 1
Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal
Amplification- Real Time Fluorescence Assay)
U20223 UStar Biotechnologies (Hangzhou) Ltd. 1 R

COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit 20203400212 Wuhan EasyDiagnosis Biomedicine Co., Ltd. 1 R
LightPower iVA SARS-CoV-2 1st RT-rPCR kit VA.A02-055H Viet A Technology corporation 1 R
TaqPath Covid-19 Combo Kit A47814 Thermo Fisher Scientific 1 u
Simplexa COVID-19 Direct and Simplexa COVID-19 Positive control
Pack
MOL4150, MOL4160 DiaSorin 1 u
One-Step RT-PRC COVID-19 kit Thai Duong Version 1.0 SK128COVO1 Sunstar Joint Stock Company R 1
awaiting awaiting
SAMBA II SARS-CoV-2 Test 8500-12 Diagnostics for the Real World Ltd
submission submission

Diagnovital SARS-CoV-2 Real Time PCR Kit 09065025, 09065050, 09065100 RTA Laboratories 1 R
awaiting
RealStar SARS-CoV-2 RT-PCR kit 1.0 821015, 821019 altona Diagnostics GmbH
submission 1
awaiting awaiting
Wondfo SARS-CoV-2 Real-Time RT PCR assay W275P001 and W275P002 Guangzhou Wondfo Biotech Co., Ltd
submission submission

RADI COVID-19 Detection Kit RV008 KH Medical Co., Ltd 1 1

awaiting awaiting
SarbecoV E-gene EAV 40-0776-96 TIB MOLBIOL Syntheselabor GmbH
submission submission

awaiting awaiting
Isopollo COVID-19 detection kit (real-time) 52227 M monitor Inc.
submission submission
SARS-CoV-2 virus Antibody Tests: progress of the active applications in the emergency use listing assessment pipeline

Dossier QMS Desk

Product name Product code(s) Manufacturer name
review Assessment
awaiting awaiting
DPP COVID-19 IgM/IgG System 65-9572-0 Chembio Diagnostic Systems Inc
submission submission
2019-nCoV IgGIgM Rapid Test Cassette (Whole BloodSerumPlasma) awaiting awaiting
INCP-402B Hangzhou AllTest Biotech Co. Ltd.
submission submission
Diagnostic Kit for SARS-CoV-2 IgG/IgM Antibody (Colloidal Gold) awaiting awaiting
R-423-20-C, R-423-25-C Shanghai Kehua Bioengineering Co., Ltd.
submission submission
One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody awaiting awaiting
CG2057 Getein Biotech Inc.
(Colloidal Gold) submission submission
awaiting awaiting
SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) 109.01.96.02 Biohit Healthcare (Hefei) Co., Ltd.
submission submission
52026069 awaiting awaiting
Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal gold) Genrui Biotech Inc.
submission submission
CV 10.01 awaiting awaiting
Bel test it ! COV-2 -SARS CoV- 2 specific lgM / lgG Test Kit Pharmact GmbH
submission submission
W195 awaiting awaiting
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) Guangzhou Wondfo Biotech Co., Ltd
submission submission
ITP16001-TC25 and ITP16002-TC25 awaiting awaiting
Rapid SARS-CoV-2 Antibody (IgM/IgG) Test InTec PRODUCTS, INC
submission submission

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 1 u F
information requested from
in process stage complete follow-up amendments
manufacturer

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 prequalification. This table should not be used
to inform procurement.Information may not yet be reflected here.
Last update: 23 June 2020