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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 lgG, EIA-6146

Manufactured by DRG International, Inc - http://www.drg-international.com/ 

Device identification number
150
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
03/29/2021 12:30
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
120 minutes
Subclass
Fluorescence
LOD
5 U/ml
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
97.7 % IgM
Clinical Specificity
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