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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Asan Easy Test Flu/COVID-19 Ag Combo

Manufactured by Asan Pharmaceutical Co. Ltd., South Korea - www.asanpharm.com 

Device identification number
1761
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
1230 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
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