| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Yixin Bio-Tech (Guangzhou) Co. Ltd. | Commercial: New coronavirus (SARS- Cov-2) Nucleic Acid Detection Kit(Fluorescent RT-PCR Probe Method) | Device ID: 3019 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Yixin Bio-Tech (Guangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Assay Kit (Immunochromatography Method) | Device ID: 3020 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: YouSeq Ltd. | Commercial: YouSeq SARS-COV-2 qPCR Test | Device ID: 636 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Yuno Diagnostics Co. Ltd. | Commercial: Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits | Device ID: 444 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Z Biotech Inc. | Commercial: AnyLab COVID-19 Ag Nasal Test Kit | Device ID: 2912 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Z Biotech Inc. | Commercial: AnyLab COVID-19 Ag Test Kit | Device ID: 2599 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 Antigen ELISA Kit | Device ID: 449 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 Antigen Rapid Test | Device ID: 448 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 IgM ELISA Kit | Device ID: 447 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona Antigen ELISA Kit | Device ID: 446 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona IgM ELISA Kit | Device ID: 450 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona Rapid Test | Device ID: 445 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zekmed | Commercial: Zekmed antigen rapid test cassette (colloidal gold) | Device ID: 1914 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ZEKMED Ltd. | Commercial: LUNA AG - Hybrid Antigen Test Kit | Device ID: 2837 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ZEKMED Ltd. | Commercial: ZEKMED CALLISTO Ag Antigen Rapid Test Kit | Device ID: 2943 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ZEKMED Ltd. | Commercial: ZEKMED LUNA Ag Antigen Rapid Test Kit | Device ID: 2842 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ZEKMED Ltd. | Commercial: ZEKMED LUNA Ag Antigen Rapid Test Kit (N) | Device ID: 2854 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zenum Technologies | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1031 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Diagnostics | Commercial: PerkinElmer COVID-19 Antigen Test (NS,NP) | Device ID: 2687 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Group | Commercial: COVISCREEN test for detection of IgM/IgG/IgA antibodies | Device ID: 815 | Method: Immunoassay | Target: Antibody, IgA, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ZET medical textile foreign trade Co LTD | Commercial: SOFTEC Covid-19 Antigen Test Kit | Device ID: 3515 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ZET medikal tekstil dis tic Ltd. sti | Commercial: SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT | Device ID: 2226 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Aibu Biotech Co. Ltd. | Commercial: Pluridiag SARS-COV-2 Ag Rapid Test | Device ID: 2780 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS CoV-2 Antigen Rapid Test, Anterior Nasal Check (minimal-invasiv) | Device ID: 2008 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS-CoV-2 Antigen Anterior Nasal Rapid Test (minimal invasive) | Device ID: 1842 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive) | Device ID: 1843 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: Andlucky™ COVID-19 Antigen Rapid Test | Device ID: 1296 | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 1198 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: COVID-19 IgG IgM Test | Device ID: 1298 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive) | Device ID: 1845 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: reOpenTest COVID-19 Antigen Rapid Test | Device ID: 1295 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SARS-COV-2 Ag & Influenza Combo Rapid Test | Device ID: 1839 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Anterior Nasal | Device ID: 1841 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 1840 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: Seinofy COVID-19 Antigen Rapid Test | Device ID: 2223 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SPESERA Covid-19 Antijen Hızlı Test Kaseti | Device ID: 2553 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit | Device ID: 452 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Detection Kit | Device ID: 2684 | Method: Immunoassay | Target: | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography) | Device ID: 2557 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Gene Science Co. Ltd. | Commercial: Rapid SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold) | Device ID: 2569 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Greylynx Biotech Co. Ltd. | Commercial: NADAL SARS-COV-2 Ag Rapid Test | Device ID: 2878 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Greylynx Biotech Co.,Ltd. | Commercial: NADAL GX COVID-19 Ag Test | Device ID: 3097 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Hongyu Medical Commodity Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Multiple Detection Kit | Device ID: 2310 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Hongyu Medical Commodity Co. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test Kit | Device ID: 2309 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Jiankang Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Detection Kit(Colloidal Gold) | Device ID: 2675 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Kuaye Biotechnology Co. Ltd. | Commercial: COVID-19 NAb Rapid Test | Device ID: 1966 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 1343 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 646 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: Influenza & COVID-19 Ag Combo Rapid Test | Device ID: 3095 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co. Ltd. | Commercial: RAPID TEST AntigenE GCCOV-502a | Device ID: 1240 | Method: Immunoassay | 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