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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Kewei COVID-19 IgG antibody ELISA Test Kit

Manufactured by Beijing Kewei Clinical Diagnostic Reagent Inc., China - en.keweidiagnostic.com/ 

Device identification number
69
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microtiter plate
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
60 minutes
Detection Principle
Magnetic Electrochemical
Accuracy
96 % IgG
Clinical Sensitivity
90.83 % IgG
Clinical Specificity
99.2 % IgG

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