Australia TGA ARTG recordAtellica IM HBc Total 2 (HBcT2) - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Australia TGA ARTG Registered Device · Siemens Healthcare Pty Ltd · Siemens Healthcare Diagnostics Products Ltd · Class III · Started July 25, 2024
Good Name: Siemens Healthcare Pty Ltd - Atellica IM HBc Total 2 (HBcT2) - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- July 25, 2024
- Effective Date
- July 25, 2024
- Country
- United Kingdom
- Address
- Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL
In vitro diagnostic use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human serum or plasma. This assay can be used as an aid in the diagnosis of individuals (neonates, children, adolescents, and adults) with acute or chronic hepatitis B virus (HBV) infection, and in the determination of the clinical status of HBV‑infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The assay is intended for testing serum and plasma specimens to screen 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 Atellica IM HBc Total 2 (HBcT2) - Hepatitis B virus core total antibody 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 Products Ltd in United Kingdom. The device registration started on July 25, 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.