Device Dossier

Multiple clinical chemistry constituent IVDs

Device Dossier for Multiple clinical chemistry constituent IVDs (CT889 - Multiple clinical chemistry constituent IVDs, Class 2, sponsor Randox). ARTG…

Intended purpose

Immunoassay Speciality Control materials that are intended to be used for the measurement of accuracy and precision of laboratory testing procedures for the determination of clinical chemistry hormones, autoimmune markers, enzymes and vitamins in a clinical specimen.

TGA Public Summary