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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method)

Manufactured by Beijing Bohui Innovation Biotechnology Co., Ltd., China - http://www.bohui-tech.com/ 

Device identification number
2055
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Physical Support
Card, Dipstick
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Lineages detected
Commercial Status
Unknown
Last Update
2021-06-09 08:27:08 CET
Assay Type
Immuno-Antibody
Method
Immunochromatography
Time
15 minutes
Detection Principle
Colloidal gold
LOD
0 AU/mL
Calibration
Not evaluated
Crossreactivity
Not evaluated
Fp
0 %
Fn
0 %
Precision
Not evaluated
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
100 % IgM
Clinical Specificity
97.1 % IgG
Clinical Specificity
97.1 % IgM
Type of antigen
Other

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