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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Novel Coronavirus Neutralizing Antibody Assay Reagent Kit

Manufactured by Hangzhou Realy Tech Co., Ltd, China - www.realytech.com 

Device identification number
1802
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antibody
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
40 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.44 % (228 samples are proven negative of 229 negative specimens.)
Fn
0 % 120 samples are proven negative of 120 positive specimens.
Precision
Evaluated
Accuracy
99.71 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.9 %
Clinical Specificity
99.56 %

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