Australia TGA ARTG record

Immunohistology cell marker IVDs

Australia TGA ARTG Registered Device · Beckman Coulter Australia Pty Ltd · Immunotech SAS a Beckman Coulter Company · Class IIa · Started June 05, 2015

Good Name: Beckman Coulter Australia Pty Ltd - Immunohistology cell marker IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: June 05, 2015
Effective Date: June 05, 2015

Sponsor

Name: Beckman Coulter Australia Pty Ltd

Manufacturer

Name: Immunotech SAS a Beckman Coulter Company
Country: France
Address: 130 Avenue de Lattre de Tassigny BP177, Marseille, Cedex 9, 13276

Intended purpose

IVDs that are intended to be used in histology and cytology to provide information about the presence and localisation of specific proteins and antigens

About this record

Access comprehensive regulatory information for Immunohistology cell marker IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Immunotech SAS a Beckman Coulter Company in France. The device registration started on June 05, 2015.

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.