Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Origio). ARTG record, intended purpose,…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
The HBA Sperm Hyaluronan Binding Assay is an in vitro diagnostic indicated for use; - As a component of the standard analysis of semen in the diagnosis of suspected male infertility. -As a component of analyses of either raw or processed semen for determining the proper course of IVF treatment of infertility.