| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2（ COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) | Device ID: 2491 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen CAS-Envision Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Detection Kit | Device ID: 2152 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huaree Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | Device ID: 2812 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Huian Biosci Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2414 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kingfocus Biomedical Engineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography) | Device ID: 2941 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (GICA) | Device ID: 1813 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lvshiyuan Biotechnology Co. Ltd. | Commercial: Green Spring SARS-CoV-2 Antigen-Rapid test-Set | Device ID: 2109 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2233 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay) | Device ID: 5751 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1967 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay) | Device ID: 1968 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1178 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | Device ID: 1228 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit SWAB | Device ID: 2026 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Ultra-Diagnostics Biotec. Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 2017 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | Device ID: 1769 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV Ag | Device ID: 1347 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: CLINITEST Rapid Covid-19 Antigen Test | Device ID: 1218 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech Inc. | Commercial: SGTi-flex COVID-19 Ag | Device ID: 1114 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SARS-CoV-2 Rapid Antigen Test Cassette | Device ID: 2297 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 Antigen Test Kit | Device ID: 1942 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Soochow University Saier Immuno Biotech Co. Ltd. | Commercial: InstantSure Covid-19 Ag CARD | Device ID: 3015 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: INFO Covid-19 Ag Test | Device ID: 2584 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER Covid-19 Ag Test | Device ID: 1751 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: TEST IT Covid-19 Ag Test | Device ID: 1689 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: TOYO Covid-19 Ag Test | Device ID: 1722 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA CORONADIAG Ag | Device ID: 1466 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 1465 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2074 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: ENMED SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4083 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Rapid Ag Test | Device ID: 1443 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RAPIDNEXT™ SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4058 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidSens™ SARS-CoV-2 Rapid Antigen Test Kit | Device ID: 4059 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: Rapid Gold Pro SARS-CoV-2 AG Test | Device ID: 3143 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: Verino Pro SARS CoV 2 Ag Rapid Test | Device ID: 2100 | 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) | Device ID: 2742 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co. Ltd. | Commercial: The SARS-CoV-2 Antigen Assay Kit (Immunochromatography) | Device ID: 1773 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Uni-science Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 4111 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2090 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuxi Biohermes Bio & Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit（Lateral Flow Assay） | Device ID: 2143 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen AmonMed Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1763 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd. | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1278 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Jiqing Biomedical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Device ID: 1588 | Method: Immunoassay | Target: Antigen | Format: Manual, 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: 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 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: 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 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: Zhuhai Encode Medical Engineering Co. Ltd. | Commercial: ENCODE SARS-COV-2 Antigen rapid Test Device | Device ID: 1902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit (Colloidal Gold) | Device ID: 1957 | 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