HSA · registration DE0506382

Siemens Atellica IM Anti-Thyroglobulin II (aTgII)

Name: Siemens Atellica IM Anti-Thyroglobulin II (aTgII) — HSA DE0506382
Creator: Siemens Healthcare Diagnostics Products Limited
Keywords: Siemens Atellica IM Anti-Thyroglobulin II (aTgII), Siemens Atellica IM Anti-Thyroglobulin II (aTgII), DE0506382, Immunology, HSA

SingaporeImmunologyClass BSiemens Healthcare Diagnostics Products Limited

Verified

Official record identity

Registration number: DE0506382
Model name: Atellica IM aTgII MCM; Atellica IM aTgII QC; Atellica IM aTgII; Atellica IM aTgII
Model identifier: 11201751; 11201752; 11201759; 11201761
Registration date: November 16, 2021
Source update date: March 05, 2025

Classification

Risk class: Class B
Published category: Immunology

Published parties

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

Official description

The Atellica® IM Anti-Thyroglobulin II (aTgII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroglobulin in human serum and plasma (dipotassium EDTA, lithium heparin, sodium heparin) using the Atellica® Analyzer. Anti-thyroglobulin (aTg, TgAb) measurements are used as an aid in the diagnosis of Hashimoto’s and Graves’ diseases, which are autoimmune diseases affecting the thyroid gland.

Additional source fields

Product owner address: Gly 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.