Hepatitis B virus IVDs - ARTG 463647
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.
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.

