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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 Saliva Test Kit

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

Device identification number
1579
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
evaluated
Crossreactivity
evaluated
Precision
evaluated
Accuracy
95.3 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
90 %

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