MARK-B COVID-19 Ag S
Manufactured by BBB Inc. Obelis S.A.(BE), South Korea - www.bbbtech.com/
Device identification number
1234
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Photonic ring resonance
LOD
24 TCID50/ml
Clinical Sensitivity
98.5 %
Clinical Specificity
98.5 %
Notes
Atomated Sandwich, Magnetic Electrochemical
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