Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined
Manufactured by Edinburgh Genetics Limited - https://eggenetics.com/
Device identification number
662
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Fingertip
Target
Antibody
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
03/29/2021 12:32
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
Clinical Sensitivity
98.43 %
Clinical Specificity
99.31 %
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