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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 IgM ELISA

Manufactured by Mediagnost, Germany - mediagnost.de 

Device identification number
1627
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Strip
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
ELISA
Accuracy
85 %
Clinical Sensitivity
66.7 % (CI range: 66.7-75%)
Clinical Specificity
98 %
Type of antigen
RBD

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