Device Dossier

Biological stain IVDs

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

Intended purpose

Stains that are intended to be used specifically as an IVD, either alone or in combination with others, for the viualisation of structures and/or other intra/extra cellular elements in biological tissues.

TGA Public Summary