Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

Show advanced filters
Download as JSON or XML
536 records found
CE Marking Manufacturer Commercial Name Method Target Format Navigate
CE Marking: Yes Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Commercial: Wantai SARS-CoV-2 Ag Rapid Test (colloidal gold) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd Commercial: Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd Commercial: Tigsun COVID-19 Antigen Saliva Rapid Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Tigsun Diagnostics Co. Ltd Commercial: Tigsun COVID-19 Antigen Rapid Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Savant Biotechnology Co., Ltd Commercial: SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Savant Biotechnology Co., Ltd Commercial: Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography) Method: Immunochromatography Target: Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co., Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Kit Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co., Ltd Commercial: SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Lepu Medical Technology Co., Ltd Commercial: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 total antibody rapid test Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc Commercial: COVID19 Antigen Rapid Test Kit Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Jinwofu Bioengineering Technology Co.,Ltd Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co., Ltd. Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co., Ltd Commercial: Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Hotgen Biotech Co., Ltd Commercial: Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV IgM Antibody Determination Kit Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV IgG/IgM Antibody Rapid Test Kit Method: Immunoassay Target: Antibody, IgG, IgM Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV IgG Antibody Determination Kit Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co., Ltd Commercial: Covid-19 Antigen Rapid Test Kit Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Beijing Beier Bioengineering Co., Ltd Commercial: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) Method: Immunoassay Target: Antibody, IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Beijing Abace Biology Co., Ltd Commercial: COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Becton Dickinson Commercial: Veritor System Rapid Detection of SARS-CoV-2 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: BBB INC; Obelis S.A.(BE) Commercial: MARK-B COVID-19 Ag S Method: Immunoassay Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: B-bio Co., Ltd. Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: B-bio Co., Ltd. Commercial: ChekR™ COVID-19 IgM/IgG Rapid test Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: AZZ Commercial: Covid PRESTO Test rapide COVID-19 IgG/IgM Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Autobio Diagnostics Co., Ltd Commercial: SARS-CoV-2 IgG/IgM CLIA Microparticle detection kit Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Atlas Medical Commercial: Atlas COVID-19 IgG/IgM Test Cassette Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 Neutralizing Antibody FIA Method: Immunoassay Target: Antibody Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 IgG/IgM Rapid Test Device Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 Antigen Saliva Test Kit Method: Immunoassay Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 Antigen Rapid Test Device Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 & M. pneumoniae Antigen Combo Test Device Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 & Influenza A/B Antigen Combo Test Device Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Asan Pharmaceutical CO., LTD Commercial: Asan Easy Test Flu/COVID-19 Ag Combo Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Asan Pharmaceutical CO., LTD Commercial: Asan Easy Test COVID-19 IgG/IgM Method: Immunoassay Target: IgG, IgM Format: Manual Go to details
CE Marking: Yes Manufacturer: Artron Laboratories Inc. Commercial: Artron COVID-19 IgM/IgG Antibody Test Method: Immunoassay Target: Antibody, IgG, IgM Format: Automated, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Artron Laboratories Inc Commercial: COVID - 19 Antigen Test Kit Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Applied Biological Materials Inc Commercial: GenomeCov9 IgM/IgG Rapid Test Kit Method: Immunoassay Target: Antibody, IgG, IgM Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Apollo Biomedical LLC Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: APLUS Diagnostics Laboratuvar San.Tic.A.S. Commercial: SMARAPIDTEST Method: Immunoassay Target: Antibody, Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD. Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold) Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Anhui DeepBlue Medical Technology Co., Ltd Commercial: COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold) Method: Immunoassay 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