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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

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

Device identification number
1611
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
5.07 U/ml
Calibration
Not Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
96.67 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.11 %

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