HSA · registration DE0509838

Roche Diagnostics Elecsys® EBV IgM

Name: Roche Diagnostics Elecsys® EBV IgM — HSA DE0509838
Creator: Roche Diagnostics GmbH
Keywords: Roche Diagnostics Elecsys® EBV IgM, Roche Diagnostics Elecsys® EBV IgM, DE0509838, Immunology, HSA

SingaporeImmunologyClass CRoche Diagnostics GmbH

Verified

Official record identity

Registration number: DE0509838
Model name: Elecsys EBV IgM; Elecsys EBV IgM; PreciControl EBV IgM/VCA IgG
Model identifier: 08355258190; 08355274190; 08355428190
Registration date: September 25, 2024

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

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.

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.