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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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104 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
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: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test Device ID: 4054 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 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/Nasopharyngeal/Saliva) Device ID: 4057 Method: Immunochromatography Target: Antigen Format: 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: Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva) Device ID: 4050 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 Slim Device ID: 4053 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing) Device ID: 4052 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing) Device ID: 4051 Method: Immunochromatography Target: Antigen Format: Other Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test Device ID: 2594 Method: Immunochromatography Target: Antigen Format: Lab-based, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test Strip Device ID: 4045 Method: Immunochromatography 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 & Influenza A/B Antigen Nasal Test Kit Device ID: 2280 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19 & Influenza A/B& RSV Antigen Nasal Test Kit Device ID: 5803 Method: Immunochromatography Target: Antigen Format: 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 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: COVID-19 Antigen Rapid Test Device Device ID: 24760 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: COVID-19 Antigen Saliva Test Kit Device ID: 1579 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: 2037 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Assure Tech (Hangzhou) Co. Ltd. Commercial: COVID-19& Influenza A/B& RSV Antigen Combo Rapid Test Device ID: 5824 Method: Immunoassay 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 (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: 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: ECOTEST COVID-19 Antigen Rapid Test Device Device ID: 4075 Method: Immunoassay Target: Antigen Format: 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: 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: 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: SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) for self testing Device ID: 4107 Method: Immunoassay Target: Antigen Format: 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 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 (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: 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) Device ID: 2325 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 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 Antigen Rapid Test (Nasal Swab) Device ID: 2257 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) for self testing Device ID: 2529 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: SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2390 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2392 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou AllTest Biotech Co. Ltd. Commercial: SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) Device ID: 2396 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: COVID-19 + Flu A&B + RSV Antigen Combo Rapid Test Cassette(Nasal Swab) Device ID: 4120 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: COVID-19 + Flu A&B +RSV Antigen Combo Rapid Test Cassette(Nasal Swab /Nasopharyngeal Swab) Device ID: 24752 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette(Nasal Swab /Nasopharyngeal Swab) Device ID: 24751 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette(Nasal Swab) Device ID: 4119 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Hangzhou Biotest Biotech Co. Ltd. Commercial: COVID-19 + Flu A&B+ RSV+ Adenovirus Antigen Combo Rapid Test Cassette (Nasal Swab) Device ID: 4121 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