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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

FAMEX Coronavirus (2019-nCoV) Antigentest

Manufactured by FAGO MEDÄ°KAL SANAYÄ° TÄ°CARET Ltd. ÅžTÄ°., Turkey - http://famextestkit.com/ 

Device identification number
2053
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Dipstick, Strip
Target type
Nucleic acid
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Saliva, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
famex antigen test kit verbesserte version
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
100 TCID50/ml
Analytical Sensitivity
97.7 %
Analytical Specificity
98 %
Clinical Sensitivity
97.7 %
Clinical Specificity
98 %

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