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 Key Diagnostics Pty Ltd, manufactured by ViennaLab Diagnostics GmbH in Austria. The device registration started on February 16, 2016.
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 intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.The technology utilises PCR and reverse hybridisation.