Device Dossier

Multiple clinical chemistry constituent IVDs

Device Dossier for Multiple clinical chemistry constituent IVDs (CT889 - Multiple clinical chemistry constituent IVDs, Class 3, sponsor Radiometer). ARTG…

Intended purpose

Intended for use with the AQT90 FLEX analyser as an assayed liquid quality control serum to monitor the precision of laboratory testing procedures for Troponin T, Troponin I, CKMB, Myoglobin, NT Pro BNP analytes, C-Reactive Protein, D-Dimer, Human Chorionic Gonadotropin and Procalcitonin.

TGA Public Summary