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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 IgG/IgM Duo

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

Device identification number
585
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
3 minutes
Analysis of cross reactivity
Evaluated
False positives
Evaluated
False negatives
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