GenBody FIA COVID-19 Ag
Manufactured by GenBody Inc., South Korea - www.genbody.co.kr
Device identification number
1297
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://genbody.co.kr/bbs/board.php?bo_table=human01&wr_id=22
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
LOD
898 TCID50/ml
Accuracy
92.95 %
Clinical Sensitivity
89.47 %
Clinical Specificity
96.43 %
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