ARTG 372323Clinical chemistry substrate IVDs
ARTG ID: 372323 · Origio Australasia Pty Ltd · Cooper Surgical Inc · Class IIa · Started August 06, 2021
Good Name: Origio Australasia Pty Ltd - Clinical chemistry substrate IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 372323
- Start Date
- August 06, 2021
- Effective Date
- August 06, 2021
- Country
- United States of America
- Address
- 95 Corporate Drive, Trumbull, CT, 06611
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.
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 registered under ARTG number 372323 and 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.