ARTG 441110Hepatitis E virus IVDs
ARTG ID: 441110 · Roche Diagnostics Australia Pty Limited · Roche Diagnostics GmbH · Class IIb · Started February 15, 2024
Good Name: Roche Diagnostics Australia Pty Limited - Hepatitis E virus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 441110
- Start Date
- February 15, 2024
- Effective Date
- February 15, 2024
- Country
- Germany
- Address
- Sandhofer Strasse 116, Mannheim, D-68305
For the in vitro quantitative and/or qualitative determination of Hepatitis E antibodies in human clinical samples to provide information about the status of infection
Access comprehensive regulatory information for Hepatitis E virus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 441110 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Diagnostics GmbH in Germany. The device registration started on February 15, 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.