Device Dossier

Viral infectious disease IVDs

Device Dossier for Viral infectious disease IVDs (CT355 - Viral infectious disease IVDs, Class 2, sponsor Bio-Rad Laboratories). ARTG record, intended…

Intended purpose

Unassayed non reactive control reagent with in vitro Diagnotsic assay procedure that are intended to be used to provide a means of estimating precision and has the potential for detecting systematic deviations from specific laboratory testing procedure about infection with or exposure to one or a number of viral diseases.

TGA Public Summary