| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: COVID-19 and Influenza A+B Rapid Antigen Combo Test | Device ID: 2845 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: Influenza Antigen A/B Rapid Test | Device ID: 2846 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: Ninonasal-Autotest | Device ID: 2281 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NINGBO LVTANG BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Device ID: 4049 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nulife | Commercial: Surety | Device ID: 2868 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Dipstick Self Test | Device ID: 3100 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 Ag Self Test | Device ID: 2806 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL SELF TEST - COVID19 Ag | Device ID: 3694 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PHASE Scientific International Limited | Commercial: INDICAID COVID-19 Rapid Antigen Self-Test | Device ID: 3150 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID 19-Ag | Device ID: 2830 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID-19 Ag Saliva | Device ID: 2829 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Home Test COVID-19 Ag | Device ID: 3615 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | 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: 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: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & Influenza A+B Antigen Combo Rapid Test (For Self-Testing) | Device ID: 3124 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test (Saliva) for self-testing | Device ID: 3114 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit(Swab) for self-testing | Device ID: 2984 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) (Self-testing) | Device ID: 3108 | Method: Immunochromatography | Target: Antigen | Format: 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: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19（SARS-CoV-2）Antigen Rapid Test Kit (Nasal Swab) - self-test | Device ID: 3080 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method) (Nasal swab) | Device ID: 3104 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Everbest Machinery lndustry Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 3125 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 Reagent Technology Co. Ltd. | Commercial: SARS-CoV-2 antigen IVD kit NASAL | Device ID: 3029 | 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: 3999 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCOV Antigen Rapid Test | Device ID: 5766 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: 3270 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: AQUILAVIE ® SARS-CoV-2 Ag Self-test Kit (Nasal Swab) | Device ID: 3041 | Method: Immunochromatography | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: AQUILAVIE ® SARS-CoV-2 Ag Self-test Kit (Saliva) | Device ID: 3043 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2 Ag Self-test Kit (Nasal Swab) | Device ID: 3040 | Method: Immunochromatography | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2 Ag Self-test Kit (Saliva) | Device ID: 3042 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 AG/Influenza A&B Combo Rapid Test Cassette | Device ID: 2617 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody IgG-IgM Rapid Test Cassette | Device ID: 2616 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody Neutralizing Rapid Test Cassette | Device ID: 2615 | Method: Immunochromatography | Target: Antibody, IgG | 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: Unibioscience AS | Commercial: Unibioscience Covid-19 Rapid Antigen Saliva Test | Device ID: 2522 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience® COVID-19 Ag Home Test | Device ID: 2826 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: EasyNAT COVID-19 RNA Test | Device ID: 3135 | Method: Other | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID19-CHECK1 ANTIGEN | Device ID: 1956 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Viola Diagnostics Systems-Tulip Diagnostics | Commercial: PerkinElmer® COVID-19 Antigen Test | Device ID: 3147 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Åžirketi | Commercial: Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi | Device ID: 5829 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Şirketi | Commercial: VISION COVID-INF A/B- RSV- ADENO MULTI RAPID TEST KIT | Device ID: 5831 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: RapidFor SARS-CoV-2 Rapid Antigen Test Kit (Nasal) | Device ID: 3611 | Method: Immunochromatography | Target: Antigen | Format: 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 |
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