Bordetella IVDs - ARTG 452605
Access comprehensive regulatory information for Bordetella IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 452605 and sponsored by Becton Dickinson Pty Ltd, manufactured by CerTest Biotec SL in Spain. The device registration started on June 18, 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.
Automated real-time qPCR IVDs designed for the qualitative detection of Bordetella spp; in order to provide information about infection with or exposure to Bordetella spp bacteria in patients suspected of respiratory infection, by using nasopharyngeal swabs and nasopharyngeal aspirates.