Singapore HSA registration DE0509838
Roche Diagnostics Elecsys® EBV IgM
Singapore·CLASS C IVD·Roche Diagnostics GmbH·Registered September 25, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509838
- Registration Date
- September 25, 2024
- Retention Due Date
- September 24, 2025
Product description
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.
Product Owner
- Short Name
- Roche Diagnostics GmbH
- Address
- Sandhofer Strasse 116, 68305 Mannheim, GERMANY
Registrant
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
- Model Name(s)
- Elecsys EBV IgM Elecsys EBV IgM PreciControl EBV IgM/VCA IgG
- Model Identifier(s)
- 8355258190 8355274190 8355428190
About this record
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.
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