Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

abia SARS-CoV- IgG/IgM

Manufactured by AB Dianostic Systems GmbH, Germany - www.ab-ds.de/ 

Device identification number
913
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
120 minutes
Subclass
Fluorescence
Clinical Sensitivity
100 %
Clinical Specificity
95.31 %

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