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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID19 Antigen Rapid Test Kit

Manufactured by Beijing Kewei Clinical Diagnostic Reagent Inc, China - en.keweidiagnostic.com/ 

Device identification number
1778
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Card, Lateral flow
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-12-21 10:54:17 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
19.3 U/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
3.82 %
Precision
Evaluated
Accuracy
98.56 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.18 %

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