| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Metas Biomedical Inc. | Commercial: ImmTek COVID-19 Antigen Rapid Test | Device ID: 1928 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1481 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test | Device ID: 2343 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Device ID: 2506 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Immunochromatography) | Device ID: 3178 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co.， Ltd. | Commercial: SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | Device ID: 4067 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: NanoRepro AG | Commercial: NanoRepro SARS-CoV-2 Antigen Rapid Test | Device ID: 2200 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit - Nasal Swab (for Self-Test use) | Device ID: 2303 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Novatech Tıbbi Cihaz Ürünleri Sanayi ve Ticaret A.Ş. | Commercial: SARS CoV-2 Antigen Rapid Test | Device ID: 2157 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 | Device ID: 2672 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 / Saliva | Device ID: 2197 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: COVID-19 Antigen Professional Rapid Test | Device ID: 2686 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1341 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Sofia Flu + SARS Antigen FIA | Device ID: 2682 | Method: Immunoassay | Target: Antigen | Format: Automated, Lab-based, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Red Cell Biyoteknoloji A.Ş. | Commercial: Red Cell COVID-19 Self Test | Device ID: 3972 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Reszon Diagnostics International Sdn. Bhd. | Commercial: Reszon COVID-19 Rapid Antigen Test (Nasal Swab) | Device ID: 2938 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: BioGerm SARS-CoV-2 Antigen Self Test | Device ID: 3039 | Method: Immunochromatography | Target: Antigen | Format: 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: 3356 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay) | Device ID: 2166 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, 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 REETOO BIOTECHNOLOGY CO. LTD | Commercial: SARS-CoV-2 Antigen Rapid Self-test Kit (Colloidal Gold) | Device ID: 5738 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | Device ID: 3086 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay) | Device ID: 3617 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Uni-medica Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 2999 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2/Influenza A/B/RSV Antigen Rapid Test Kit | Device ID: 24740 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: Automatic ImmunoAssay System - HP-AFS/1 | Device ID: 1095 | Method: Nephelometry | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co. Ltd. | Commercial: POCT Immunoassay System - HP-083/4 | Device ID: 1094 | Method: Nephelometry | Target: Antigen | Format: Near POC / POC, Semi-automated | 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: TargetingOne Technology (Beijing) Corporation | Commercial: TARGETINGONE® SARS-CoV-2 Antigen Test | Device ID: 3066 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA Autotest Nasal Covid-19 | Device ID: 2054 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: RapidFor™ SARS-CoV-2 & FLU A/B Antigen Combo Test | Device ID: 4065 | 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 + FLU A/B + RSV Combo Test Kit | Device ID: 5804 | 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 + FLU A/B + RSV+ADV Combo Test Kit | Device ID: 5816 | Method: Chromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2 +FLUA/B + RSV + ADV + M. Pneumoniae Combo Test Kit | Device ID: 5834 | Method: Chromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor™ SARS-CoV-2+RSV Combo Test Kit | Device ID: 5810 | 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: Verino Pro SARS CoV 2 Ag Rapid Test （self test） | Device ID: 2759 | 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: 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: 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: 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: 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: 2264 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Higia Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 3051 | Method: Immunochromatography | Target: Antigen | Format: 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: Zybio Inc. | Commercial: SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) | Device ID: 2201 | Method: Immunoassay | Target: Antigen | Format: Manual | 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