Alinity i HBsAg Next Confirmatory Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Access comprehensive regulatory information for Alinity i HBsAg Next Confirmatory Assay - 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 Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Ireland Diagnostics Division in Ireland. The device registration started on September 23, 2021.
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.
The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) used for the confirmation of the presence of Hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heartbeating),that have been collected up to 24 hours after death, by means of specific antibody neutralization on the Alinity i system.