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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

TOYO Covid-19 Ag Test

Manufactured by Turklab, Turkey - www.turklab.com.tr/ 

Device identification number
1722
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
LOD
0 AU
Calibration
not evaluated
Crossreactivity
evaluated
Precision
not evaluated
Accuracy
97.57 %
Reproducibility
evaluated
Robustness
not evaluated
Clinical Sensitivity
93.18 %
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