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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 ELISA (IgA)

Manufactured by EUROIMMUN AG, Germany - www.coronavirus-diagnostics.com 

Device identification number
160
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgA
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Subclass
Fluorescence
Clinical Sensitivity
100 % (Range:91.7 - 100)
Clinical Specificity
92.4 % (Range:88.2- 92.4)

Related Scientific Literature

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