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

COVID-19 In Vitro Diagnostic Medical Device - detail

BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test

Manufactured by RapiGEN Inc., South Korea - www.rapigen-inc.com/eng 

Device identification number
1606
CE Marking
Yes
HSC common list (RAT)
×No
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Clinical Sensitivity
90.2 %
Clinical Specificity
100 %

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