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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Rapid Test

Manufactured by Zhejiang Orient Gene Biotech Co.,Ltd.

Device identification number
646
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Clinical Sensitivity
87.9 % IgG
Clinical Sensitivity
97.2 % IgM
Clinical Specificity
100 % IgG
Clinical Specificity
100 % IgM

Related Scientific Literature

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