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 Share…

Intended purpose

The test is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine,Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital,Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline, d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine.For in vitro diagnostic use only. The test is intended for laboratory health professionals use only.

TGA Public Summary