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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BIOCREDIT COVID-19 IgG/IgM Combo

Manufactured by RapiGEN Inc., South Korea - www.rapigen-inc.com/eng 

Device identification number
1716
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
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 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.67 % (4/150)
False negatives
0 % 0/52
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %

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