HSA · registration DE0506659

Siemens Atellica IM Quantitative HBsAg (QHBs)

Name: Siemens Atellica IM Quantitative HBsAg (QHBs) — HSA DE0506659
Creator: Siemens Healthcare Diagnostics Products Limited
Keywords: Siemens Atellica IM Quantitative HBsAg (QHBs), Siemens Atellica IM Quantitative HBsAg (QHBs), DE0506659, Immunology, HSA

SingaporeImmunologyClass CSiemens Healthcare Diagnostics Products Limited

Verified

Official record identity

Registration number: DE0506659
Model name: Atellica IM PW3; Atellica IM QHBs; Atellica IM QHBs QC; Atellica IM QHBs MCM; Atellica IM Multi‑Diluent 14
Model identifier: 10995666; 11200643; 11200644; 11200651; 11200662
Registration date: February 17, 2022
Source update date: April 24, 2025

Classification

Risk class: Class C
Published category: Immunology

Published parties

Product owner: Siemens Healthcare Diagnostics Products Limited
Registrant / registration holder: SIEMENS HEALTHCARE PTE. LTD.

Official description

The Atellica® IM Quantitative HBsAg (QHBs) assay is for in vitro diagnostic use in the quantitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma (dipotassium EDTA and lithium heparin) that are confirmed positive for HBsAg using the Atellica® Analyzer

Additional source fields

Product owner address: Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom
Registrant address: 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615

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.