ADVIA Centaur HCV - Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Access comprehensive regulatory information for ADVIA Centaur HCV - Hepatitis C virus immunoglobulin G (IgG) 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 Inc in United States of America. The device registration started on July 19, 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.
An in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human serum or plasma (EDTA, lithium heparin, or sodium heparin). The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals (neonates, children, adolescents, and adults) with symptoms of hepatitis and in individuals at risk for hepatitis C infection. 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.