Humasis COVID-19 Ag Test
Manufactured by Humasis, South Korea - http://www.humasis.com/en/
Device identification number
1263
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 08:07:30 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Fp
0 %
Fn
5.6 %
Accuracy
97.4 %
Clinical Sensitivity
95.3 %
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