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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)

Manufactured by Xiamen Wiz Biotech Co. Ltd., China - www.wizbiotech.com 

Device identification number
1887
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card
Target type
Antigen
Specimen
Saliva, Sputum, Stool
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
170 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
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