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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

FREND COVID-19 SP

Manufactured by NanoEntek, South Korea - www.nanoentek.com 

Device identification number
1411
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge
Target type
Antibody
Targets
spike protein
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.nanoentek.com/theme/nanont2_en/shop/02/product01_view.php?it_id=1599640498
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
3 minutes
Analysis of cross reactivity
0 % for tested agents
Clinical Sensitivity
97.06 %
Clinical Specificity
96.3 %
Type of antigen
spike protein

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