CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: COVIFIND COVID-19 Antigen Self Test | Device ID: 2923 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 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: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - self-testing | Device ID: 2983 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit | Device ID: 1501 | Method: Immunoassay | Target: Antigen | Format: Lab-based, Manual, 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: 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: 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: 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: 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: 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 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: 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: 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: 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 |
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: 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: 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 |
CE Marking: Yes | Manufacturer: Wuhan Uni-science Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Nasal swab) | Device ID: 3853 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co. Ltd. | Commercial: COVID-19 Ag & Flu A/B Combo Self Test | Device ID: 5720 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Qualitative Test | Device ID: 5746 | Method: Immunochromatography | Target: Antigen | Format: 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 |
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