Siemens Atellica IM Hepatitis B surface Antigen II (HBsII) - HSA Registration DE0510275
Access comprehensive regulatory information for Siemens Atellica IM Hepatitis B surface Antigen II (HBsII) 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 DE0510275 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on January 22, 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 Atellica® IM Hepatitis B surface Antigen II (HBsII) assay is for in vitro diagnostic use in the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA, lithium heparin and sodium heparin) using the Atellica® Analyzer. The assay may be used in conjunction with other serological and clinical information to diagnose individuals (neonates, infants, children, adolescents, and adults) with acute or chronic hepatitis B infection. The assay may be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. The assay may be used for screening 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.