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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid SARS-CoV-2 Antigen Test Card

Manufactured by Xiamen Boson Biotech Co., Ltd, China - http://www.bosonbio.com 

Device identification number
2264
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Anterior nasal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-23 06:44:50 CET
Comments
CE0123 by notified body TUV SUD Product Service GmbH Please set HSC to yes.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
130 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.8 %
Fn
3.23 %
Precision
Evaluated
Accuracy
98.72 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.77 % ( (Antigen))
Clinical Specificity
99.2 %
Type of antigen
Nucleoprotein

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