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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.

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Class IIa
Class IIa
Clinical chemistry substrate IVDs
Australia TGA ARTG Registered Device
Good Name: Origio Australasia Pty Ltd - Clinical chemistry substrate IVDs
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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.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
August 06, 2021
Effective Date
August 06, 2021
Manufacturer
Country
United States of America
Address
95 Corporate Drive, Trumbull, CT, 06611