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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

STANDARD Q COVID-19 Ag Test

Manufactured by SD BIOSENSOR Inc, South Korea - http://sdbiosensor.com/xe/ 

Device identification number
345
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Detection Principle
Magnetic Electrochemical
LOD
1981 TCID50/ml
Crossreactivity
Evaluated
Clinical Sensitivity
96.52 %
Clinical Specificity
99.68 %

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