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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

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

Device identification number
1983
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge, Lateral flow, Latex
Target
Antibody
Specimen
Serum
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-08-25 10:34:52 CET
Comments
Absoludy COVID-19 NAb is intended for detection of nuetralizing antobody to SARS-CoV-2 virus (COVID-19) in human serum specimens. This product is for professional use.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Other
Method
Immunoassay
Measurement
Semiquantitative
Time
6 minutes
Subclass
Neutralization Antibody (NAb)
LOD
20 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
100 %
Type of antigen
Other

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