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Pneumocystis IVDs - ARTG 454765

Access comprehensive regulatory information for Pneumocystis IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 454765 and sponsored by Becton Dickinson Pty Ltd, manufactured by CerTest Biotec SL in Spain. The device registration started on July 08, 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.

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Class IIb
ARTG 454765
Class IIb
Pneumocystis IVDs
ARTG ID: 454765
Good Name: Becton Dickinson Pty Ltd - Pneumocystis IVDs
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Intended Purpose

Automated real-time PCR IVDs that are intended to be used in testing to provide information about infection with or exposure to Pneumocystis, in respiratory samples (bronchoalveolar lavage) from individuals suspected of respiratory infection.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
454765
Start Date
July 08, 2024
Effective Date
July 08, 2024
Manufacturer
Country
Spain
Address
Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840