Human genetics-related IVDs - ARTG 461285
Access comprehensive regulatory information for Human genetics-related IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 461285 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Devyser AB in Sweden. The device registration started on August 29, 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.
An IVD intended for qualitative and semi-quantitative device for discrimination, relative quantification and monitoring to perform various human genetics-related tests and procedures (e.g mixed chimerism using genomic DNA (gDNA) from peripheral blood or bone marrow from patients following hematopoietic stem cell transplantation (HSCT), donor-derived cell-free DNA (dd cfDNA) in plasma from patients following kidney Transplantation). The procedure is manual and is intended to be used by qualified laboratory professionals only.