Device Dossier

Clinical chemistry therapeutic drug monitoring IVDs

Device Dossier for Clinical chemistry therapeutic drug monitoring IVDs (CT860 - Clinical chemistry therapeutic drug monitoring IVDs, Class 2, sponsor…

Intended purpose

IVDs that are intended for the in vitro quantitative measurement of busulfan in human heparinized plasma using automated clinical chemistry analysers. Measurements obtained can be used to aid in management of individuals prescribed intravenous busulfan

TGA Public Summary