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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 (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
not found
False negatives
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