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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Gmate® COVID-19 Ag Saliva

Manufactured by Philosys Co., Ltd., South Korea - http://www.philosys.com/ 

Device identification number
1854
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cartridge
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
N.A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
5.07 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
-
Fn
-
Precision
Evaluated
Accuracy
98.87 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.83 %
Clinical Specificity
99.6 %
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