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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Cormay Rapid SARS-CoV-2 IgG/IgM Ab

Manufactured by CORMAY, Poland - cormay.pl/index.php?lang=_en 

Device identification number
1074
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
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
Chromatography
Measurement
Qualitative
Time
10 minutes
Accuracy
97.72 % IgM
Accuracy
98.52 % IgG
Clinical Sensitivity
96.52 % IgG
Clinical Sensitivity
94.07 % IgM

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