Device Dossier

Biological stain IVDs

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

Intended purpose

Chemicals, stains and/or solution intended to 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 and specimens, including kits and methodology instructions for use such as Rapid Diff/romanowsky, Mycobacterium, Kleihauer, Trichrome, Gram stain kits as may be required within class 2 CT215.

TGA Public Summary