2019-nCoV-IgM Assay Reagent Kit (CMIA)
Manufactured by Hangzhou Realy Tech Co. Ltd., China - www.realytech.com
Device identification number
1794
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
IgM
Specimen
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
40 minutes
Detection Principle
Chemiluminescence
False positives
0.97 %
False negatives
7.78 %
Accuracy
98.17 %
Clinical Sensitivity
92.22 %
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