Enterococcus IVDs
Access comprehensive regulatory information for Enterococcus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Becton Dickinson Pty Ltd, manufactured by CerTest Biotec SL in Spain. The device registration started on July 02, 2021.
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 testing to provide information about infection with or exposure to Enterococcus bacteria; for example Vancomycin resistance through the detection and differentiation of vanA and vanB genes using PCR methods.