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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgM/IgG Rapid Test Kit

Manufactured by Ring Biotechnology Co., Ltd, China - www.ringbio.com/ 

Device identification number
603
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Crossreactivity
Evaluated
Fp
Evaluated
Fn
Evaluated
Accuracy
95.12 %
Clinical Sensitivity
85 %
Clinical Specificity
98.39 %

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