HSA · registration DE0510168

Roche Diagnostics Elecsys® Anti-HEV IgG

Name: Roche Diagnostics Elecsys® Anti-HEV IgG — HSA DE0510168
Creator: Roche Diagnostics GmbH
Keywords: Roche Diagnostics Elecsys® Anti-HEV IgG, Roche Diagnostics Elecsys® Anti-HEV IgG, DE0510168, Immunology, HSA

SingaporeImmunologyClass CRoche Diagnostics GmbH

Verified

Official record identity

Registration number: DE0510168
Model name: Elecsys® Anti-HEV IgG; Elecsys® Anti-HEV IgG; PreciControl Anti-HEV IgG
Model identifier: 09044639190; 09044647190; 09044655190
Registration date: December 19, 2024
Source update date: September 16, 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

Immunoassay for the in vitro qualitative and quantitative determination of IgG antibodies to the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti‑HEV IgG assay is used as an aid to detect a recent or past HEV 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.