AFIAS COVID-19/Flu Ag Combo
Manufactured by Boditech Med Inc - http://www.boditech.co.kr/eng/
Device identification number
1449
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-03-26 03:08:29
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Fluorescence
LOD
56 AU ()
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
99.3 % ()
Reproducibility
Evaluated
Robustness
Not Evaluated
Clinical Sensitivity
96.8 % ()
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