HSA · registration DE0510278Siemens Atellica IM TSH3-Ultra II (TSH3ULII)
SingaporeImmunologyClass BSiemens Healthcare Diagnostics Inc
Official record identity
- Registration number
- DE0510278
- Model name
- Atellica IM TSH3-Ultra II (TSH3ULII); Atellica IM TSH3ULII Master Curve Material (TSH3ULII MCM); Atellica IM Multi‑Diluent 15; Atellica IM TSH3-Ultra II (TSH3ULII)
- Model identifier
- 11208707; 11208876; 11200798; 11208706
- Registration date
- January 23, 2025
- Source update date
- September 11, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Siemens Healthcare Diagnostics Inc
- Registrant / registration holder
- SIEMENS HEALTHCARE PTE. LTD.
Official description
The Atellica® IM TSH3‑Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Additional source fields
- Product owner address
- 511 Benedict Avenue, Tarrytown, NY 10591, United States
- 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.