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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

EDI Novel Coronavirus COVID-19 IgG ELISA Kit

Manufactured by Epitope Diagnostics Inc., United States - www.epitopediagnostics.com/ 

Device identification number
157
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
120 minutes
Clinical Sensitivity
100 % IgG
Clinical Specificity
100 % IgG

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