Device Dossier

Biological stain IVDs

Device Dossier for Biological stain IVDs (CT215 - Biological stain IVDs, Class 2, sponsor Roche Diagnostics). ARTG record, intended purpose, GMDN…

Intended purpose

Dyes, chemicals, stains or solutions that are intended to be used specifically as an IVD, either alone or in combination with others, for the visualisation of structures and/or other intra/extracellular elements in biological tissues.

TGA Public Summary