Australia TGA ARTG record

Bordetella IVDs

Australia TGA ARTG Registered Device · Becton Dickinson Pty Ltd · CerTest Biotec SL · Class IIb · Started June 18, 2024

Good Name: Becton Dickinson Pty Ltd - Bordetella IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: June 18, 2024
Effective Date: June 18, 2024

Sponsor

Name: Becton Dickinson Pty Ltd

Manufacturer

Name: CerTest Biotec SL
Country: Spain
Address: Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840

Intended purpose

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.

About this record

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 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.