Australia TGA ARTG record

Troponin IVDs

Australia TGA ARTG Registered Device · Beckman Coulter Australia Pty Ltd · Immunotech SAS a Beckman Coulter Company · Class IIb · Started March 30, 2018

Good Name: Beckman Coulter Australia Pty Ltd - Troponin IVDs

Device classification

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

Registration information

Start Date: March 30, 2018
Effective Date: March 30, 2018

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

The Access hsTnI assay and calibrator systems are a chemiluminescent immunoassay for high sensitivity quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).

About this record

Access comprehensive regulatory information for Troponin IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Immunotech SAS a Beckman Coulter Company in France. The device registration started on March 30, 2018.

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.