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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Xfold immunoassay

Manufactured by Xfold Imaging, Finland - www.xfoldimaging.com/ 

Device identification number
1058
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Method
Immunoassay
Measurement
Quantitative
Time
15 minutes
Subclass
Fluorescence
Detection Principle
Immunofluorescence
Calibration
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated

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