Instrument/analyser IVDs
Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Bio-Strategy Pty Ltd, manufactured by AliveDx Suisse SA in Switzerland. The device registration started on February 14, 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.
The MosaiQ 125 is intended for use as an automated system for the in vitro qualitative, semi-quantitative, or quantitative (depending on the intended purpose of the individual MosaiQ magazine used) detection of antibodies to autoimmune diseases in human serum. It is intended for professional use within a clinical laboratory environment.