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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-CoV2 Influenza A&B Ag combo

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

Device identification number
2536
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab
Pathogens detected
Influenza A, Influenza B, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-03 01:18:09 CET
Comments
.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1230 U/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
-
Fn
-
Precision
Evaluated
Accuracy
-
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
94.7 %
Clinical Specificity
97.4 %

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