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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 IgM/IgG Duo Test

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

Device identification number
346
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
20 µg/ml ((IgM, IgG))
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Not evaluated
Accuracy
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
99.1 %
Clinical Specificity
95.09 %

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