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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CRT (COVID 19 RAPID TEST)

Manufactured by Oncosem Onkolojik Sistemler San. ve Tic. A.S., Turkey - www.oncosem.com 

Device identification number
1163
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
https://oncosem.com/en/crt-2/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Fp
1 %
Fn
5.14 %
Accuracy
97.3 %
Clinical Sensitivity
94.85 %

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