Device Category Dossier

CT860 - Clinical chemistry therapeutic drug monitoring IVDs

Device Category Dossier for CT860 - Clinical chemistry therapeutic drug monitoring IVDs. Australian ARTG records, sponsors, device class — compiled by…

Therapeutic drug monitoring assays are in vitro immunoassays that quantitatively measure drug concentrations in human serum or plasma samples using chemiluminescent microparticle immunoassay technology. These assays are used to monitor serum levels of anticonvulsant and cardiac drugs to help ensure appropriate therapeutic management and to aid in the diagnosis of drug overdose.