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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid)

Manufactured by BTNX Inc., Canada - www.btnx.com/ 

Device identification number
1684
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
1000 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
5 %
Precision
Evaluated
Accuracy
99.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95 %
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