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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Neutralizing Antibody FIA

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

Device identification number
1910
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Not available
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Type of antigen
Other
Notes
Fluorescence detection

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