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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.

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Class IIb
ARTG 463647
Class IIb
Hepatitis B virus IVDs
ARTG ID: 463647
Good Name: Siemens Healthcare Pty Ltd - Hepatitis B virus IVDs
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Intended Purpose

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.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
463647
Start Date
October 04, 2024
Effective Date
October 04, 2024
Manufacturer
Country
United Kingdom
Address
Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL