| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag COVID-19 IgM/IgG Rapid Test | Device ID: 428 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS CoV 2 Ag Rapid Test | Device ID: 2103 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS CoV 2 Ag Rapid Test (self test) | Device ID: 2099 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS-CoV-2 Ag | Device ID: 2768 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS-CoV-2 Ag Rapid Test (self-test) | Device ID: 2758 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS CoV 2 Ag Rapid Test | Device ID: 1246 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Ag FIA Test | Device ID: 2105 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Ag Rapid Test | Device ID: 2102 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Ag Saliva Rapid Test | Device ID: 1980 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit | Device ID: 2106 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Wellion SARS-CoV-2 Antigen Rapid Test | Device ID: 2163 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Weifang Kanghua Biotech | Commercial: RAPIDTECH Test Rapide Antigène SARS-CoV-2 | Device ID: 1453 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Weihai Dishang Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (LFIA) | Device ID: 2804 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Weihai Dishang Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (LFIA) | Device ID: 2803 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2688 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Well Biotech | Commercial: COVID-19 IgM/IgG Rapid Test (Colloidal Gold) | Device ID: 1027 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio Inc. | Commercial: careGENE COVID-19 RT-PCR kit | Device ID: 493 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio Inc. | Commercial: careGENE N-CoV RT-PCR kit | Device ID: 494 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: WHPM | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 1630 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WHPM | Commercial: First Sign SARS-CoV-2-Antigen-Test | Device ID: 1724 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: COVID-19 Test IgM/ IgG | Device ID: 983 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: Willi Fox COVID-19 Antigen rapid Test | Device ID: 1276 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: Willi Fox Covid-19 IgM/ IgG rapid test | Device ID: 633 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wizbio Solutions | Commercial: WizDx COVID-9 CrystalMix PCR Kit | Device ID: 953 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wizbio Solutions | Commercial: WizDx COVID-9 Real-time PCR Kit | Device ID: 954 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: WIZCHEM Co. Ltd. | Commercial: COVICHEK COVID-19 Ag KIT | Device ID: 2661 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WIZCHEM Co. Ltd. | Commercial: COVICHEK COVID-19 Ag Saliva HT | Device ID: 2652 | Method: Immunochromatography | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Won Medical Co. Ltd. | Commercial: Wonmed Covid-19 Ag | Device ID: 3038 | Method: Immunochromatography | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 & Influenza A/B Nucleic Acid Test Kit | Device ID: 3998 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit | Device ID: 2755 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit | Device ID: 2098 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 and Influenza A+B Antigen Combo Test Kit Plus | Device ID: 3987 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Saliva/Swabs) | Device ID: 3985 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: Novel Coronavirus IgG antibody test kit (colloidal gold method) | Device ID: 432 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: Novel Coronavirus IgM antibody test kit (colloidal gold method) | Device ID: 430 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 and Influenza A+B Antigen Combo Test Kit (Colloidal Gold) | Device ID: 3986 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Quantitative Test Kit (Immunofluorescence Method) | Device ID: 3996 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit | Device ID: 3988 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (Immunofluorescence Method) | Device ID: 3994 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (MCLIA) | Device ID: 4002 | Method: CLIA | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 nucleic acid test kit | Device ID: 431 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Total Antibody & Neutralizing Antibody Test Kit | Device ID: 3997 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Healthcare Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2444 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Device ID: 435 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR) | Device ID: 1971 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: SARS CoV 2 IgM/IgG Duo Test Kit (Colloidal Gold) | Device ID: 1889 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: SARS CoV 2 IgM/IgG Duo Test Kit (Colloidal Gold) | Device ID: 2450 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2742 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) - NS-NP-S | Device ID: 1888 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan J.H. Bio-Tech. Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit ( Colloidal Gold ) | Device ID: 2991 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements