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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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66 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co., Ltd Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Device ID: 1457 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co., Ltd Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) Device ID: 1865 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: ACON Biotech (Hangzhou) Co., Ltd. Commercial: FIAflex SARS-CoV-2 Antigen FIA Device ID: 1669 Method: Immunoassay Target: Antigen Format: Lab-based, 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 Device ID: 1371 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 Nasal Test Kit Device ID: 3106 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 & M. pneumoniae Antigen Combo Test Device Device ID: 1372 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: COVID-19 Antigen Saliva Test Kit Device ID: 1579 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd Commercial: ECOTEST COVID-19 Antigen Rapid Test Device (Nasal swab, Nasopharyngeal swab, Oropharyngeal swab) Device ID: 770 Method: Immunoassay Target: Antigen Format: Manual, 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 Device ID: 1370 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: COVID-19 Antigen Rapid Test Device Device ID: 2270 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: ECOTEST COVID-19 Antigen Nasal Test Kit Device ID: 2277 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: ECOTEST COVID-19 Antigen Rapid Test Device (Nasopharyngeal swab, Oropharyngeal swab) Device ID: 2350 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. Commercial: FASTEP COVID-19 Antigen Rapid Test Device Device ID: 2364 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Changzhou Biowin Pharmaceutical Co.,Ltd. Commercial: Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold) Device ID: 2871 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd. Commercial: COVID-19 Antigen Rapid Test Device Device ID: 3005 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: COVID-19 and Influenza A+B Antigen Combo Rapid Test Device ID: 1256 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test (Oral Fluid) Device ID: 1947 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: COVID-19 Antigen Test cassette (FIA) Device ID: 1254 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) Device ID: 2325 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 1258 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test) (Swab) Device ID: 1257 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd Commercial: SARS-COV-2 rapid antigen test (Swab) Device ID: 1946 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd. Commercial: COVID-19 Antigen Rapid Test (Oral Fluid) SELFTESTING Device ID: 2159 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd. Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) Device ID: 2302 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd. Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) for self testing Device ID: 2690 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co., Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) Device ID: 2257 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) Device ID: 1868 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test Cassette(Nasal Swab) Device ID: 1876 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test Device ID: 1363 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test Cassette (Nasal Swab) Device ID: 1610 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co., Ltd Commercial: COVID-19 Antigen Rapid Test Cassette(Saliva) Device ID: 1746 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Clongene Biotech Co., Ltd Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test Device ID: 1365 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Deangel Biological Engineering Co., Ltd Commercial: Novel Coronavirus S Glycoprotein Detection Kit Device ID: 1259 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd. Commercial: COVID-19 Antigen Test Cassette Device ID: 2629 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Funworld Biotech Co., Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Device Device ID: 2862 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd Commercial: COVID-19 Antigen Rapid Test Device Device ID: 1261 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol CO.,LTD Commercial: KaiBiLi COVID-19 Antigen Device ID: 2085 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Jucheng Medical Products Co., Ltd Commercial: SARS-CoV-2 Ag Rapid Test Kit Device ID: 2979 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Laihe Biotech Co., Ltd Commercial: LYHER Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Device ID: 1215 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Laihe Biotech Co., Ltd. Commercial: Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold Device ID: 2224 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD. Commercial: COVID-19 Antigen Rapid Test Device(Colloidal Gold) Device ID: 2139 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) Device ID: 1795 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen rapid test Device ID: 1743 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) Device ID: 1220 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) Device ID: 2018 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Realy Tech Co., Ltd Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) Device ID: 1796 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Sejoy electronics & Instruments Co., Ltd. Commercial: GENnasal SARS-CoV.2 Antigen Rapid Test Device ID: 3146 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Hangzhou Sejoy Electronics & Instruments Co.,Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Device ID: 2671 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Sejoy Electronics&Instruments Co.,LTD. Commercial: SARS-CoV-2 Antigen Rapid Test Cassette Device ID: 1945 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Singclean Medical Products Co., Ltd. Commercial: COVID-19 Test Kit (Colloidal Gold Method) Device ID: 2210 Method: Immunochromatography Target: Antigen 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