Singapore HSA registration DE0509881
Roche Diagnostics Elecsys® IL-6
Singapore·CLASS C IVD·Roche Diagnostics GmbH·Registered October 08, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509881
- Registration Date
- October 08, 2024
- Change Notification Approval Date
- January 15, 2025
- Retention Due Date
- October 07, 2025
Product description
Elecsys IL-6 is an immunoassay for the in vitro quantitative determination of Interleukin‑6 (IL‑6) in human serum and plasma. It is intended for use in conjunction with clinical evaluation to aid in: ▪ management of critically ill patients as an early indicator for acute inflammation ▪ diagnosis of sepsis in neonates with suspected or confirmed bacterial infection 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)
- IL-6 Calset PreciControl Multimarker Elecsys IL-6 Elecsys IL-6 Elecsys IL-6
- Model Identifier(s)
- 5109469190 5341787190 9015604190 9015612190 9015612214
About this record
Access comprehensive regulatory information for Roche Diagnostics Elecsys® IL-6 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 DE0509881 and owned by Roche Diagnostics GmbH. The device was registered on October 08, 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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