ARTG 473150Fungal infectious disease IVDs
ARTG ID: 473150 · R-Biopharm Pty Ltd · R-Biopharm AG · Class IIa · Started December 16, 2024
Good Name: R-Biopharm Pty Ltd - Fungal infectious disease IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 473150
- Start Date
- December 16, 2024
- Effective Date
- December 16, 2024
- Name
- R-Biopharm AG
- Country
- Germany
- Address
- An der neuen Bergstrasse 17, Darmstadt, 64297
For in vitro diagnostic use. RIDA®GENE Pneumocystis jirovecii is a multiplex realtime PCR for the direct qualitative and quantitative detection of Pneumocystis jirovecii from human bronchoalveolar lavage fluid (BAL). The RIDA®GENE Pneumocystis jirovecii multiplex real-time PCR is intended to use as an aid in diagnosis for respiratory infections caused by Pneumocystis jirovecii.
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.