Clinical chemistry-specific protein IVDs - ARTG 462525
Access comprehensive regulatory information for Clinical chemistry-specific protein IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 462525 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Immunotech SAS a Beckman Coulter Company in France. The device registration started on September 23, 2024.
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.
IVDs that are paramagnetic particle, chemiluminescent immunoassays used for the qualitative and/or quantitative determination of proteins specific to clinical chemistry in human serum and plasma using the automated DxI Access Immunoassay Analyzers.