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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

MARK-B COVID-19 Ag

Manufactured by BBB Inc., South Korea - www.bbbtech.com 

Device identification number
2315
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cartridge
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-02 10:33:18 CET
Comments
Updated the variants detected.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
23.9 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
5 %
Precision
Evaluated
Accuracy
97.2 ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.4 % ((Antigen))
Clinical Specificity
100 % ( (Antigen))
Type of antigen
Nucleocapsid protein

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