AFIAS COVID-19, Viral Antigen (automated)
Manufactured by Boditech Med Inc, South Korea - https://www.boditech.co.kr/en
Device identification number
1248
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Fluorescence
Clinical Sensitivity
87.5 %
Clinical Specificity
96.5 %
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