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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



COVID-19 Antigen Test

Manufactured by Redcell Biyoteknoloji, Turkey - en.redcell.com.tr/ 

Device identification number
1715
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
50000 AU
Calibration
not evaluated
Crossreactivity
evaluated
Fp
1.15 % (Out of 261 samples 3 of them were false positives)
Fn
4.92 % (Out of 122 samples 6 of them were false negatives)
Precision
evaluated
Accuracy
99.2 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
95.08 %
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