Interpretive software IVDs
Access comprehensive regulatory information for Interpretive software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Sequencing Solutions Inc in United States of America. The device registration started on October 26, 2020.
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.
Interpretative software algorithms intended to be applied to a clinical result or set of results obtained through testing in order to identify and/or formulate additional clinical information which may then be used to guide patient management