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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2-IgG-EIA-BEST

Manufactured by Vector-Best, Russia - www.vector-best.ru/en/ 

Device identification number
1463
CE Marking
Yes
HSC common list (RAT)
×No
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
90 minutes
LOD
0.13 IU/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
Precision
Not evaluated
Accuracy
100 % IgG
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
100 % 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