COVID-19 Antigen Rapid Test Kit(Swab)
Manufactured by Chongqing iSIA BIO-Technology Co., Ltd - www.isiabio.com.cn
Device identification number
1937
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Commercial Status
Commercialised
Last Update
2021-03-29 04:55:49
Comments
the sample is sending to the european country for testing
Assay Type
Immuno-Antigen
Time
15 minutes
LOD
0.9 AU ()
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
98 % ()
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
97 % ()
Clinical Specificity
100 % ()
Type of antigen
Other
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