ENZY-WELL SARS-CoV-2 IgM
Manufactured by DIESSE Diagnostica Senese SPA, Italy - www.diesse.it/
Device identification number
982
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
135 minutes
Analysis of cross reactivity
Evaluated
Clinical Sensitivity
87.7 %
Clinical Specificity
97 %
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