ARTG 463647Hepatitis B virus IVDs
ARTG ID: 463647 · Siemens Healthcare Pty Ltd · Siemens Healthcare Diagnostics Products Ltd · Class IIb · Started October 04, 2024
Good Name: Siemens Healthcare Pty Ltd - Hepatitis B virus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 463647
- Start Date
- October 04, 2024
- Effective Date
- October 04, 2024
- Country
- United Kingdom
- Address
- Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL
In vitro diagnostic use in the quantitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma that are confirmed positive for HBsAg. Measurements of hepatitis B surface antigen (HBsAg) are used as an aid in the management of hepatitis B virus (HBV) infection.
Access comprehensive regulatory information for Hepatitis B 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 463647 and sponsored by Siemens Healthcare Pty Ltd, manufactured by Siemens Healthcare Diagnostics Products Ltd in United Kingdom. The device registration started on October 04, 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.