HSA · registration DE0509881

Roche Diagnostics Elecsys® IL-6

Name: Roche Diagnostics Elecsys® IL-6 — HSA DE0509881
Creator: Roche Diagnostics GmbH
Keywords: Roche Diagnostics Elecsys® IL-6, Roche Diagnostics Elecsys® IL-6, DE0509881, Immunology, HSA

SingaporeImmunologyClass CRoche Diagnostics GmbH

Verified

Official record identity

Registration number: DE0509881
Model name: IL-6 Calset; PreciControl Multimarker; Elecsys IL-6; Elecsys IL-6; Elecsys IL-6
Model identifier: 05109469190; 05341787190; 09015604190; 09015612190; 09015612214
Registration date: October 08, 2024
Source update date: January 15, 2025

Classification

Risk class: Class C
Published category: Immunology

Published parties

Product owner: Roche Diagnostics GmbH
Registrant / registration holder: ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD

Official 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.

Additional source fields

Product owner address: Sandhofer Strasse 116, 68305 Mannheim, GERMANY
Registrant address: 8 Kallang Avenue, #10-01/09, Aperia, Singapore 339509

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.