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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



RIDA®@QUICK SARS-CoV-2 Antigen

Manufactured by R-Biopharm AG, Germany - www.r-biopharm.com 

Device identification number
1846
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Dipstick, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
237 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
N/A
Fn
N/A
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.7 % (ct<30 )
Clinical Specificity
97.4 %
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