HSA · registration DE0508308

Siemens Atellica IM Thyroglobulin (Tg)

Name: Siemens Atellica IM Thyroglobulin (Tg) — HSA DE0508308
Creator: Siemens Healthcare Diagnostics Products Limited
Keywords: Siemens Atellica IM Thyroglobulin (Tg), Siemens Atellica IM Thyroglobulin (Tg), DE0508308, Immunology, HSA

SingaporeImmunologyClass CSiemens Healthcare Diagnostics Products Limited

Verified

Official record identity

Registration number: DE0508308
Model name: Atellica IM Multi‑Diluent 11; Atellica IM Multi‑Diluent 11; Atellica IM Tg MCM; Atellica IM Thyroglobulin (Tg); Atellica IM Thyroglobulin (Tg)
Model identifier: 10995641; 10995642; 11200449; 11200450; 11200534
Registration date: July 18, 2023
Source update date: July 29, 2024

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 Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica® Analyzer. Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.

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.