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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Rapid Test Device

Manufactured by Azure Biotech Inc, United States - www.azure.bio 

Device identification number
1912
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Not available
Assay Type
Immuno-Antibody
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
98.7 % IgG
Accuracy
97.7 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.7 % IgM
Clinical Sensitivity
98.8 % IgG
Clinical Specificity
99.1 % IgM
Clinical Specificity
98.7 % IgG
Type of antigen
Other

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