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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



OnSite COVID-19 IgG/IgM Rapid Test

Manufactured by CTK Biotech, Inc, United States - https://ctkbiotech.com/ 

Device identification number
902
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Not found
Clinical Sensitivity
98.2 %
Clinical Specificity
97.8 %

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