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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Accudiag SCoV-2 IgM ELISA Kit

Manufactured by Diagnostic Automation/Cortez Diagnostics Inc., United States - www.rapidtest.com 

Device identification number
1193
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgM
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Method
ELISA
Measurement
Qualitative
Time
150 minutes
Accuracy
98.95 % IgM
Clinical Sensitivity
92.5 % IgM
Notes
Manual or automated

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