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Roche Diagnostics Elecsys® IL-6 - HSA Registration DE0509881

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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CLASS C IVD
DE0509881
Roche Diagnostics Elecsys® IL-6
HSA Registration Number: DE0509881
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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.

Device 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 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