Roche Diagnostics Elecsys Anti-HBs III - HSA Registration DE0510553
Access comprehensive regulatory information for Roche Diagnostics Elecsys Anti-HBs III 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 DE0510553 and owned by Roche Diagnostics GmbH. The device was registered on April 04, 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.
Immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma. The assay, also in conjunction with other relevant laboratory results and clinical information, may be used ▪ as an aid in the determination of an individual’s immune status to hepatitis B virus (HBV), ▪ within the scope of hepatitis B vaccination to assess the necessity and success of vaccination, ▪ as a supplemental test to prevent transmission of HBV to recipients of blood, blood components, cells, tissue, and organs, and ▪ as an aid in monitoring the course of disease following HBV infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.