Roche Diagnostics Elecsys® EBV IgM - HSA Registration DE0509838
Access comprehensive regulatory information for Roche Diagnostics Elecsys® EBV 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 DE0509838 and owned by Roche Diagnostics GmbH. The device was registered on September 25, 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 Epstein‑Barr virus (EBV) in human serum and plasma. The test is intended for use as an aid in the diagnosis of an infectious mononucleosis and the determination of the EBV infection stage. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.