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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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98 records found
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