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

The UTAK controls are for use as quality control material for measuring the levels of anitepileptic drugs, antifungals, antipsychotics, immunosuppressive agents, pentobarbital, meprobamate, methotrexate, methylmalonic acid and other TDMs in serum, whole blood and urine. They are intended for use on a continuous basis so that a statistical evaluation of testing performance can be obtained.

TGA Public Summary