Device Dossier

Clinical chemistry hormone IVDs

Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Martin Flynn). ARTG record, intended…

GMDN category: CT850 - Clinical chemistry hormone IVDs

Intended purpose

HYE-5769 - The DRG:HYBRiD-XL® Hepcidin 25 (bioactive) is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Hepcidin 25 in serum of plasma (EDTA-, heparin-, or citrate plasma. Only for use with the DRG:HYBRiD-XL® Analyzer.

TGA Public Summary