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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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646 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Finecare SARS-CoV-2 IgG Test Device ID: 1191 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Finecare SARS-CoV-2 IgM/IgG Test Device ID: 1211 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Finecare™ 2019-nCoV RBD Antibody Test Device ID: 2925 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondfo SARS-CoV-2 Antibody Test (lateral flow method) Device ID: 461 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondof SARS-CoV-2 IgG Antibody Test (Lateral Flow Method) Device ID: 1212 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondof SARS-CoV-2 IgM Antibody Test Device ID: 1306 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. Commercial: Wondof SARS-CoV-2 IgM Antibody Test (Lateral Flow Method) Device ID: 1213 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Guanxhow Fenghua Bioengineering Co. Ltd. Commercial: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit Device ID: 673 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: H&Z Life Science Co. Ltd. Commercial: Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay) Device ID: 1172 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: HA TECH PTY Ltd. Commercial: SARS-CoV-2 Rapid Antigen Test Kit (RAT-01) Device ID: 4160 Method: Immunochromatography Target: Antibody Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: HA TECH PTY Ltd. Commercial: SARS-CoV-2 Rapid Antigen Test Kit (RAT-01) Device ID: 4158 Method: Immunochromatography Target: Antibody Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette Device ID: 208 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 and M.pneumoniae IgG Combo Rapid Test Device ID: 1386 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Device ID: 1385 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 IgG Rapid Test (cassette) Device ID: 1383 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 IgG Rapid Test (strip) Device ID: 1384 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 IgG/IgM Rapid Test Device ID: 1381 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 IgG/IgM Rapid Test Cassette Device ID: 1377 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 IgG/IgM Rapid Test Dipstick Device ID: 1382 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) Device ID: 2416 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma) Device ID: 2327 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) Device ID: 2403 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) Device ID: 2404 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Bioer Technology Co. Ltd. Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method) Device ID: 2059 Method: Immunochromatography Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Protective Antibodies) Device ID: 4123 Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Device ID: 212 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) Device ID: 1921 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Combo) Device ID: 4114 Method: Immunochromatography Target: Antibody Format: Near POC / POC, Other Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) Device ID: 1922 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co. Ltd. Commercial: 2019-nCoV IgG/IgM Rapid Test Device ID: 568 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co. Ltd. Commercial: Clungene COVID-19 IgM/IgG Rapid Test Cassette Device ID: 675 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Laihe Biotech Co. Ltd. Commercial: LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) Device ID: 477 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. Commercial: COVID-19 Neutralizing Antibody Rapid Test Device(Colloidal Gold) Device ID: 2142 Method: Immunochromatography Target: Antibody Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. Commercial: nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum) Device ID: 2141 Method: Immunochromatography Target: Antibody Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co. Ltd. Commercial: 2019-nCOV IgG/LgM Rapid Test Device Device ID: 570 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co. Ltd. Commercial: 2019-nCoV-IgG Assay Reagent Kit (CMIA) Device ID: 1793 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co. Ltd. Commercial: Novel Coronavirus Neutralizing Antibody Assay Reagent Kit Device ID: 1802 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co. Ltd. Commercial: Novel coronavirus neutralizing antibody Rapid Test Device Device ID: 1896 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. Commercial: COVID-19 IgG/IgM Rapid Test Cassette Device ID: 1970 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette Device ID: 2062 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: 2019-nCoV Ab Test (Colloidal Gold) Device ID: 1000 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. Commercial: Covid-19 IgG/IgM test kit (Colloidal Gold Method) Device ID: 1001 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: COVID-19 IgG/IgM Antibody Test(Colloidal Gold) Device ID: 1632 Method: Immunoassay Target: Antibody Format: Lab-based Go to details
CE Marking: Yes Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) Device ID: 857 Method: Immunoassay Target: Antibody Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Healgen Scientific Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Device ID: 677 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hecin Scientific Inc. Commercial: COVID-19 IgM Antibody Rapid Test Kit Device ID: 478 Method: Immunoassay Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hefei Biohit Healthcare Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method) Device ID: 1637 Method: Immunochromatography Target: Antibody Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hoyotek Biomedical Co. Ltd. Commercial: Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold) Device ID: 1930 Method: Immunoassay Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. Commercial: COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold) Device ID: 2527 Method: Immunochromatography Target: Antibody Format: Manual Go to details
CE Marking: Yes Manufacturer: Humasis Co. Ltd. Commercial: Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test Device ID: 5719 Method: Immunochromatography Target: Antibody 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