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

COVID-19 In Vitro Diagnostic Medical Device - detail

Anti-SARS-CoV-2 IgG ELISA

Manufactured by Mediagnost - https://mediagnost.de 

Device identification number
1625
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Physical Support
Strip
Target
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-03-18 09:03:45
Assay Type
Immuno-Antibody
Method
ELISA
Analitical Specificity
98.6 ()
Crossreactivity
Beta Corona HKU1, SARS-CoV, VZV, HCV, HAV, HBV, EBV, CMV, HSV
Accuracy
96.99 ()
Clinical Sensitivity
95.3 ((69.4-95.3)%)

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