Siemens Atellica™ IM Hepatitis C (aHCV) - HSA Registration DE0509297
Access comprehensive regulatory information for Siemens Atellica™ IM Hepatitis C (aHCV) 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 DE0509297 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on May 16, 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.
The Atellica® IM Hepatitis C (aHCV) assay is for in vitro diagnostic use in the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) 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 aid in the diagnosis of individuals (neonates, children, adolescents, and adults) with symptoms of hepatitis and in individuals at risk for hepatitis C infection. The assay is intended for testing serum and plasma specimens 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.