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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab)

Manufactured by Hangzhou Realy Tech Co., Ltd, China - www.realytech.com 

Device identification number
1789
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
3.83 %
Precision
Evaluated
Accuracy
98.79 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.17 %
Clinical Specificity
99.9 %

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