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

COVID-19 In Vitro Diagnostic Medical Device - detail

GENEDIA W COVID-19 Ag

Manufactured by Green Cross Medical Science Corp., South Korea - www.greencrossms.com/eng/main.do?lang=EN 

Device identification number
1144
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-11 09:31:09 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
750 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
95.3 %
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Sensitivity
90.1 %
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