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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

KNAX-SMART SARS-CoV-2 IgM/IgG (N)

Manufactured by Asan Pharmaceutical Co., Ltd., South Korea - http://www.asapharm.com 

Device identification number
2571
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-03 01:17:23 CET
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
3 AU
Fn
15 AU
Precision
Evaluated
Accuracy
100 % IgG
Accuracy
100 % IgM
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
88.7 %
Clinical Specificity
98.1 %
Type of antigen
Nucleocapsid protein

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