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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AESKULISA SARS-CoV-2 NP IgA

Manufactured by Aesku.Diagnostics, Germany - www.aesku.com 

Device identification number
1091
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgA
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Additional info: http://en.diagreat.com/Private/Files/20200402/6372142236666949104672720.pdf https://www.aesku.com/index.php/diagnostics/aeskulisa-elisa-test-kits/infectious-serology-elisa/item/397
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Detection Principle
Magnetic Electrochemical
Clinical Sensitivity
98.3 %
Clinical Specificity
99 %

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