Acquired genetic alteration IVDs
Access comprehensive regulatory information for Acquired genetic alteration IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Qiagen Pty Ltd, manufactured by Qiagen GmbH in Germany. The device registration started on March 05, 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.
The therascreen PIK3CA RGQ PCR kit is intended for use as a companion diagnostic test, to aid clinicians in identification of breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA mutation detected result.