WHO Emergency Use Listing for In vitro diagnostics (IVDs) Detecting SARS-CoV-2 Nucleic Acid
Last update: 8 July 2020
Date Listed Product name Product code(s) Manufacturer
cobas SARS-CoV-2 Qualitative assay for
03 April 2020 09175431190 and 09175440190 Roche Molecular Systems, Inc.
use on the cobas 6800/8800 Systems
07 April 2020 Primerdesign Ltd COVID-19 genesig Real-Time PCR assay Z-Path-COVID-19-CE Primerdesign Ltd.
09 April 2020 Abbott Realtime SARS-CoV-2 09N77-090 and 09N77-080 Abbott Molecular Inc.
24 April 2020 PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay SY580 PerkinElmer Inc.
07 May 2020 Real-time fluorescent RT-PCR kit for detecting 2019-nCoV MFG030011 BGI Europe A/S
Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA
14 May 2020 DA0930, DA0931 and DA0932 Da An Gene Co., Ltd. Of Sun Yat-sen University
(PCR- Fluorescence Probing)
19 May 2020 Multiple Real-Time PCR Kit for Detection of 2019-nCoV CT8233-48T Beijing Applied Biological Technologies Co. Ltd., (XABT)
21 May 2020 FTD SARS-CoV-2 (FTD-114-32) 11416300 Fast Track Diagnostics Luxembourg S.à r.l.
Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR
22 May 2020 RR-0485-02 Shanghai ZJ Bio-Tech Co., Ltd
Kit
08 June 2020 Diagnostic kit for SARS-CoV-2 Nucleic acid (Real-time PCR) KH-G-M-574-48 Shanghai Kehua Bio-engineering Co., Ltd.
Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit
11 June 2020 GZ-D2RM25 Shanghai GeneoDx Biotechnology Co., Ltd
(Real Time PCR)
15 June 2020 COVID-19 Real-Time PCR Kit HBRT-COVID-19 Chaozhaou Hybribio Biochemistry Ltd.
23 June 2020 Xpert® Xpress SARS-CoV-2 XPRSARS-COV2-10 Cepheid AB
Simplexa COVID-19 Direct and Simplexa COVID-19 Positive
06 July 2020 MOL4150, MOL4160 DiaSorin
control Pack
Final Public Reports to be posted on the website once completed
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