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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



STANDARD F COVID-19 Ag FIA

Manufactured by SD BIOSENSOR Inc, South Korea - http://sdbiosensor.com/xe/ 

Device identification number
344
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), P.1 (Gamma), P.2 (Zeta), B.1.1.529 (Omicron), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
https://bestbion.com/sars-cov-2_covid-19/
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Fluorescence
Type of antigen
nucleoprotein

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