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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, Germany - mediagnost.de 

Device identification number
1625
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Strip
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
ELISA
Analytical Specificity
98.6
Analysis of cross reactivity
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