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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ErbaLisa COVID-19 IgG ELISA

Manufactured by Erba Mannheim, United Kingdom - www.erbamannheim.com 

Device identification number
533
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
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
ELISA
Measurement
Semiquantitative
Time
50 minutes
Subclass
Sandwich, Double
Analysis of cross reactivity
Evaluated
Precision
6.37 % IgG (5.29% - 6.37%)
Clinical Sensitivity
98.3 % IgG
Clinical Specificity
98.1 % 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