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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 IgM ELISA Kit

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

Device identification number
158
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Quantitative
Time
120 minutes
Subclass
Fluorescence
Clinical Sensitivity
100 % IgM
Clinical Specificity
100 % IgM

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