COVID-19 Antigen Rapid Test Device
Manufactured by Assure Tech. (Hangzhou) Co., Ltd - http://www.diareagent.com/
Device identification number
770
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
Antigen
Specimen
Other
Commercial Status
Commercialised
Last Update
03/25/2021 06:01
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
Not available
Fn
Not available
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.7 %
Clinical Specificity
99.1 %
Notes
Rapid diagnostic test
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