Australia TGA ARTG record

Enterococcus IVDs

Australia TGA ARTG Registered Device · Becton Dickinson Pty Ltd · CerTest Biotec SL · Class IIb · Started July 02, 2021

Good Name: Becton Dickinson Pty Ltd - Enterococcus IVDs

Device classification

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

Registration information

Start Date: July 02, 2021
Effective Date: July 02, 2021

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

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.

About this record

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.