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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ChekR™ COVID-19 IgM/IgG Rapid test

Manufactured by B-bio Co., Ltd., South Korea - www.b-bio.com 

Device identification number
1613
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
not evaluated
Crossreactivity
evaluated
Fp
not found
Fn
not found
Precision
evaluated
Accuracy
97.9 %
Reproducibility
evaluated
Robustness
not evaluated
Clinical Sensitivity
95.5 %

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