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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 (SARS-CoV-2) IgA ELISA

Manufactured by Demeditec Diagnostics GmbH, Germany - www.demeditec.com/ 

Device identification number
840
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
N.A.
Target type
Antibody, IgA
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
N.A.
Reader Required
Yes
Subcategory
N.A.
Method
ELISA
Measurement
Qualitative
Analysis of cross reactivity
Evaluated
Clinical Sensitivity
100 % (7.69 - 100)
Clinical Specificity
98.26 %

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