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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 Device (Nasal Swab)

Manufactured by Assure Tech. (Hangzhou) Co., Ltd, China - www.diareagent.com 

Device identification number
2076
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-20 03:22:04 CET
Comments
Not available
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
Not available
Fn
Not available
Precision
Evaluated
Accuracy
97.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.4 %
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