Siemens Atellica IM HBc Total 2 (HBcT2) - HSA Registration DE0509250
Access comprehensive regulatory information for Siemens Atellica IM HBc Total 2 (HBcT2) 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 DE0509250 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on May 02, 2024.
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.
For qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human serum or plasma using the Atellica IM Analyzer. As an aid in the diagnosis of individuals (neonates, children, adolescents, and adults) with acute or chronic hepatitis B virus (HBV) infection, and in the determination of the clinical status of HBV‑infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. As an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. 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.