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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SCoV-2 Detect IgM ELISA

Manufactured by InBios International, United States - inbios.com/ 

Device identification number
1410
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
Target type
Antibody, IgM
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://inbios.com/scov-2-detect-igm-elisa-kit/
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
150 minutes
Detection Principle
Magnetic Electrochemical
Analysis of cross reactivity
0 % IgM for tested agents
Clinical Sensitivity
92.5 % IgM
Clinical Specificity
98.95 % IgM

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