Abbott Alinity i HBsAg Next Confirmatory - HSA Registration DE0510600
Access comprehensive regulatory information for Abbott Alinity i HBsAg Next Confirmatory in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0510600 and owned by Abbott Ireland Diagnostics Division. The device was registered on April 16, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA 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), by means of specific antibody neutralization on the Alinity i system. The HBsAg Next Confirmatory assay is intended to be used for the confirmation of samples found to be repeatedly reactive by the HBsAg Next Qualitative assay.