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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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17 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Roche (SD BIOSENSOR) Commercial: SARS-CoV-2 & Flu A/B Rapid Antigen Test Device ID: 2968 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Roche (SD BIOSENSOR) Commercial: SARS-CoV-2 & Flu A/B Rapid Antigen Test Device ID: 25547 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Roche (SD BIOSENSOR) Commercial: SARS-CoV-2 Antigen Self Test Nasal Device ID: 2323 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Roche (SD BIOSENSOR) Commercial: SARS-CoV-2 Rapid Antigen Test Device ID: 1604 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Roche (SD BIOSENSOR) Commercial: SARS-CoV-2 Rapid Antigen Test 2.0 Device ID: 25546 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Roche (SD BIOSENSOR) Commercial: SARS-CoV-2 Rapid Antigen Test 2.0 Nasal Device ID: 5839 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Roche (SD BIOSENSOR) Commercial: SARS-CoV-2 Rapid Antigen Test Nasal Device ID: 2228 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SD Biosensor Healthcare Private Limited Commercial: Ultra COVID-19 Ag Device ID: 3026 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD F COVID-19 Ag FIA Device ID: 24759 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD F COVID-19 Ag FIA Device ID: 344 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD F COVID/Flu Ag Combo FIA Device ID: 24757 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD i-Q COVID/Flu Ag Combo Test Device ID: 24756 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD M nCoV Real-Time Detection Kit Device ID: 343 Method: RT-PCR Target: Nucleic acid Format: Manual Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD Q COVID-19 Ag Test Device ID: 345 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD Q COVID-19 Ag Test 2.0 Device ID: 24758 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD Q COVID-19 Ag Test Nasal Device ID: 2052 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SD BIOSENSOR Inc. Commercial: STANDARD Q COVID-19 IgM/IgG Duo Test Device ID: 346 Method: Immunoassay Target: Antibody, IgG, IgM 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