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

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgM/IgG Rapid Test

Manufactured by BioMedomics, Inc, United States - www.biomedomics.com/ 

Device identification number
90
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2021-05-26 11:13:18 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
Crossreactivity
Reported as not possible
Clinical Sensitivity
88.66 %
Clinical Specificity
90.63 %

Related Scientific Literature

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