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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



COVID-19 Antigen Rapid Test Kit (Swab)

Manufactured by Safecare Biotech (Hangzhou) Co. Ltd, China - www.safecare.com.cn 

Device identification number
1489
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
0.5 AU
Calibration
Not Evaluated
Crossreactivity
Evaluated
Fp
2.96 %
Fn
0.56 %
Precision
Evaluated
Accuracy
98.41 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.04 %
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