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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GenSure COVID-19 Neutralizing Antibody Test (Fluorescence)

Manufactured by GenSure Biotech Inc., China - www.gensbio.com/ 

Device identification number
1826
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antibody
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
Evaluated
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Not evaluated
Robustness
Not evaluated

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