COVID19 IgG/IgM Rapid Test Kit
Manufactured by Novus Biologicals LLC, Bio-techne brand - https://www.novusbio.com
Device identification number
685
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
04/21/2021 10:16
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Detection Principle
Colloidal gold
Crossreactivity
Evaluated
Clinical Sensitivity
1 U/ml IgM
Clinical Sensitivity
0.5 U/ml IgG
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