Roche Diagnostics Elecsys® Anti-HEV IgM - HSA Registration DE0509913
Access comprehensive regulatory information for Roche Diagnostics Elecsys® Anti-HEV IgM in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509913 and owned by Roche Diagnostics GmbH. The device was registered on October 15, 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.
Immunoassay for the in vitro qualitative detection of IgM antibodies to the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti‑HEV IgM assay is used as an aid to detect an acute or recently acquired HEV infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.