SeroFlash SARS-CoV-2 IgM/IgG Antibody Detection Kit
Manufactured by Epigentek Group Inc., United States - www.epigentek.com
Device identification number
1038
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
I could not find CE-IVD proof
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Detection Principle
Colloidal gold
Analysis of cross reactivity
Reported
Accuracy
92.19 %
Clinical Sensitivity
97.8 %
Clinical Specificity
100 %
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