Device Dossier

Clinical chemistry toxicology/drug detection IVDs

Device Dossier for Clinical chemistry toxicology/drug detection IVDs (CT184 - Clinical chemistry toxicology/drug detection IVDs, Class 2, sponsor…

Intended purpose

The UTAK controls are for use as quality control material for monitoring the accuracy and precision of immunoassay procedures that measure the levels of TCAs, barbiturates, benzodiazepines, volatiles (alcohols and glycols, drugs of abuse, ethyl's metabolites, opiates, antipsychotics, caffeine, and opiates in serum, urine and whole blood

TGA Public Summary