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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)

Manufactured by Beijing Beier Bioengineering Co., Ltd, China - www.beierbio.com/ 

Device identification number
1359
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
131
Fp
Require clinical data comparison
Fn
Require clinical data comparison
Accuracy
96.77 %
Clinical Sensitivity
94.12 % IgM
Clinical Sensitivity
95.1 % IgG
Notes
Manual NAT cassette colloidal gold

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