FREND COVID-19 IgG/IgM Duo
Manufactured by NanoEntek, South Korea - www.nanoentek.com
Device identification number
585
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
3 minutes
Subclass
Fluorescence
Crossreactivity
Evaluated
Fp
Evaluated
Fn
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
97 %
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