General laboratoryware IVDs - ARTG 481647
Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 481647 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Genomic Health Inc in United States of America. The device registration started on March 04, 2025.
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 device is intended for the extraction and purification of total RNA from formalin-fixed, paraffin-embedded (FFPE) tissue sections. The product employs an optimized, semi-automated paramagnetic bead-based process including enzymatic removal of residual DNA. The product is intended for in vitro diagnostic use by laboratory professionals trained in molecular biology techniques. The product can be used in conjunction with diagnostic tests. The end user is responsible for validating its use with any diagnostic test.