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 (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
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