Clinical chemistry substrate IVDs
Access comprehensive regulatory information for Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Origio Australasia Pty Ltd, manufactured by Cooper Surgical Inc in United States of America. The device registration started on August 06, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.

