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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV IgM ELISA

Manufactured by Ansh Labs, United States - www.anshlabs.com/ 

Device identification number
915
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
N.A.
Target type
Antibody, IgM
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
Qualitative
Time
120 minutes
Analysis of cross reactivity
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
98.5 %

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