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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GA CoV-2 IgG/IgM/IgG+

Manufactured by GA Generic Assays GmbH, Germany - www.genericassays.com 

Device identification number
554
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
105 minutes
Clinical Sensitivity
98 %
Clinical Specificity
98 % ( )
Notes
Manual or automated Fluorescence

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