WHO Emergency Use Listing for In vitro diagnostics (IVDs ...

1 RoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast updated: 25 November 2021 Rapid Antigen Detection TestsDate ListedManufacturerProduct nameProduct code(s)Regulatory versionEUL application numberPackaging 17 March 2021 Premier Medical Corporation Private LimitedSure Status COVID-19 Antigen Card TestSS03P25 RoWEUL 0590-010-0025 T/kit 19 November 2020 Abbott Rapid diagnostics Jena GmbH Panbio COVID-19 Ag Rapid Test Device (NASAL) 41FK11, 41FK21CE-markEUL 0587-032-0025 T/kit 02 October 2020 Abbott Rapid diagnostics Jena GmbH Panbio COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) 41FK10, 41FK20CE-markEUL 0564-032-0025 T/kit 22 September 2020SD Biosensor, IncSTANDARD Q COVID-19 Ag Test 09 COV30 DCE-mark EUL 0563-117-00 25 T/kit Nucleic Acid Detection TestsDate ListedManufacturerProduct nameProduct code(s)Regulatory versionEUL application numberPackaging 28 September 2021KH Medical Co.

2 , COVID-19 Detection KitRV008CE-markEUL 0538-214-00100 T/kit10 December 2020 MiCo BioMed Co LtdVeri-Q PCR 316 Coronavirus disease 2019 (COVID-19) Detection System 7K105 RoWEUL 0495-188-0050 T/kit30 November 2020 Bioeksen R&D Technologies LtdBio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection 0497-190-00100 T/kit23 November 20203D biomedicine Science & Technology Co., 2019-nCoV RT-qPCR Detection Kit3103010011 RoWEUL 0488-184-00100 T/kit15 September 2020 Tellgen CorporationSARS-CoV-2 Nucleic acid detection kit based on Real-Time PCR platformPGA4102P1 (liquid) PGA4102P2 (lyophilized)CE-markEUL 0517-204-0048 T/kit48 T/kit02 September 2020 Shanghai Fosun Long March Medical Science Co., Ltd. Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (commercial name: Fosun 2019-nCoV qPCR)PCSYHF-32 PCSYHF-48 PCSYHF-96CE-markEUL 0516-203-0032 T/kit48 T/kit96 T/kit28 August 2020 Ningbo Health Gene Technologies Co.

3 , Virus Detection Diagnostic Kit (RT-qPCR Method)XC25073XC25087CE-markEUL 0494-189-0050 T/kit200 T/kit14 August 2020 Thermo Fisher ScientificTaqPath COVID 19 CE IVD RT PCR KitA48067CE-mark EUL 0525-156-001000 T/kit14 August 2020 Beijing Wantai Biological Pharmacy Enterprise Co., LtdWantai SARS-CoV-2 RT-PCRWS-1248CE-markEUL 0500-005-0048 T/kit09 July 2020 Jiangsu Bioperfectus Technologies Co.,LtdCOVID-19 Coronavirus Real Time PCR KitJC10223-1NW-50 TCE-mark EUL 0515-202-0050 T/kit23 June 2020 Cepheid ABXpert Xpress SARS-CoV-2 XPRSARS-COV2-10CE-mark EUL 0511-070-0010 T/kitNucleic Acid Detection TestsDate ListedManufacturerProduct nameProduct code(s)Regulatory versionEUL application numberPackaging 15 June 2020 Chaozhaou Hybribio Biochemistry Real-Time PCR KitHBRT-COVID-19CE-mark EUL 0535-196-0024 T/kitWHO Emergency Use Listing for In vitro diagnostics (IVDs) Detecting SARS-CoV-2 RoW: Rest of the world.

4 Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast updated: 25 November 2021 WHO Emergency Use Listing for In vitro diagnostics (IVDs) Detecting SARS-CoV-2 11 June 2020 Shanghai GeneoDx Biotechnology Co., LtdNovel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Real Time PCR)GZ-D2RM25CE-mark EUL 0513-200-0050 T/kit08 June 2020 Shanghai Kehua Bio-engineering Co., kit for SARS-CoV-2 Nucleic acid (Real-time PCR)KH-G-M-574-48 RoWEUL 0492-037-0048 T/kit22 May 2020 Shanghai ZJ Bio-Tech Co., LtdNovel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR KitRR-0485-02 RoWEUL 0486-139-0050 T/kit21 May 2020 Fast Track diagnostics Luxembourg S. SARS-CoV-2 1141630011416284CE-mark EUL 0502-193-0032 T/kit96 T/kit19 May 2020 Beijing Applied Biological Technologies Co.

5 Ltd., (XABT)Multiple Real-Time PCR Kit for Detection of 2019-nCoVCT8233-48 TRoW EUL 0491-187-0048 T/kit14 May 2020 Daan Gene Co., LtdDetection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR- Fluorescence Probing)DA0930DA0931 DA0932 RoWEUL 0493-141-0024 T/kit48 T/kit96 T/kit07 May 2020 BGI Europe A/SReal-time fluorescent RT-PCR kit for detecting 2019-nCoVMFG030011CE-mark EUL 0498-191-0050 T/kit24 April 2020 PerkinElmer Inc. PerkinElmer SARS-CoV-2 Real-time RT-PCR AssaySY580CE-mark EUL 0501-192-0048 T/kit09 April 2020 Abbott Molecular Inc. Abbott Realtime SARS-CoV-209N77-090 09N77-080CE-mark EUL 0503-027-0096 T/kitcontrols07 April 2020 Primerdesign Ltd COVID-19 genesig Real-Time PCR assayZ-Path-COVID-19-CECE-mark EUL 0489-185-0096 T/kit03 April 2020 Roche Molecular Systems, SARS-CoV-2 Qualitative assay foruse on the cobas 6800/8800 Systems0917543119009343733190 09175440190CE-mark EUL 0504-046-00192 T/kit480T/kitcontrolsAntibody Detection TestsDate ListedManufacturerProduct nameProduct code(s)

6 Regulatory versionEUL application NumberPackaging 07 December 2020 Roche diagnostics GmbHElecsys Anti-SARS-CoV-2 Qualitative assay for use on the cobas e 411/601/602/801 immunoanalyzers0920309519009203079190 09216928190CE-mark EUL 0542-118-00200 T/kit300 T/kitcontrolsFinal Public Reports to be posted on the website once completedEnd of document