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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Absoludy COVID-19 NAb Rapid

Manufactured by Absology Co., Ltd., South Korea - www.absology.co.kr 

Device identification number
1985
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Card, Lateral flow
Target
Antibody
Specimen
Serum
Commercial Status
In development
Last Update
2021-05-10 01:04:00 CET
Comments
Absoludy COVID-19 NAb Rapid is intended for detection of neutralizing antibody to SARS-CoV-2 virus (COVID-19) in human serum.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
20 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
Evaluation ongoing
Fn
Evaluation ongoing
Precision
Evaluated
Accuracy
90 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 %
Clinical Specificity
95 %
Type of antigen
Nucleoprotein

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