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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID19 IgG/IgM Rapid Test Kit

Manufactured by Novus Biologicals, United States - www.novusbio.com 

Device identification number
685
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Detection Principle
Colloidal gold
Analysis of cross reactivity
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