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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BD Kit For Rapid Detection of SARS-CoV-2

Manufactured by Becton Dickinson, United States - https://www.bd.com/en-us 

Device identification number
2282
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual
Physical Support
Cartridge, Cassette
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-11-12 12:29:38 CET
Comments
As part of surveillance activities, BD is monitoring the emergence of new mutations of SARS-CoV-2. No impact of the mutations on the performance of the device has been observed so far.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
1400 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
1 AU
Fn
5 AU
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.1 %
Clinical Specificity
99.6 %
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