Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
×No
HSC mutual recognition
×No
Format
Other
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 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