Pure Global

Fungal infectious disease IVDs - ARTG 473150

Access comprehensive regulatory information for Fungal infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 473150 and sponsored by R-Biopharm Pty Ltd, manufactured by R-Biopharm AG in Germany. The device registration started on December 16, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 473150
Class IIa
Fungal infectious disease IVDs
ARTG ID: 473150
Good Name: R-Biopharm Pty Ltd - Fungal infectious disease IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

For in vitro diagnostic use. RIDAยฎGENE Pneumocystis jirovecii is a multiplex realtime PCR for the direct qualitative and quantitative detection of Pneumocystis jirovecii from human bronchoalveolar lavage fluid (BAL). The RIDAยฎGENE Pneumocystis jirovecii multiplex real-time PCR is intended to use as an aid in diagnosis for respiratory infections caused by Pneumocystis jirovecii.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
473150
Start Date
December 16, 2024
Effective Date
December 16, 2024
Manufacturer
Country
Germany
Address
An der neuen Bergstrasse 17, Darmstadt, 64297