Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit

Manufactured by Epigentek Group Inc., United States - www.epigentek.com 

Device identification number
1044
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Subcategory
Sample preparation
Method
ELISA
Measurement
Qualitative
Time
45 minutes
LOD
0.002 µg/ml
Analysis of cross reactivity
Evaluated
Precision
Inter-assay 8%; Intra assay: 12%.

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