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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



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
Physical Support
Other
Target type
IgM
Specimen
Serum
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
40 minutes
Detection Principle
Chemiluminescence
Fp
0.97 %
Fn
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