Australia TGA ARTG recordADVIA Centaur HBsAgII - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Australia TGA ARTG Registered Device · Siemens Healthcare Pty Ltd · Siemens Healthcare Diagnostics Inc · Class III · Started July 24, 2024
Good Name: Siemens Healthcare Pty Ltd - ADVIA Centaur HBsAgII - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- July 24, 2024
- Effective Date
- July 24, 2024
- Country
- United States of America
- Address
- 511 Benedict Avenue, Tarrytown, NY, 10591
In vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA, lithium heparin and sodium heparin. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. The assay may be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. The assay may be used for screening donors whose blood or blood products are intended for transfusion or for further manufacture, or to screen donors whose cells, tissues, and organs are intended for transplant. Specimens may be obtained while the donor's heart is still beating, or from cadaveric (non-heart-beating) donors.
Access comprehensive regulatory information for ADVIA Centaur HBsAgII - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Siemens Healthcare Pty Ltd, manufactured by Siemens Healthcare Diagnostics Inc in United States of America. The device registration started on July 24, 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.