HSA · registration DE0510185Siemens Atelllica IM Anti-Thyroid Peroxidase II (aTPOII)
SingaporeImmunologyClass BSiemens Healthcare Diagnostics Inc
Official record identity
- Registration number
- DE0510185
- Model name
- Atellica IM aTPOII Master Curve Material (aTPOII MCM); Atellica IM Anti-Thyroid Peroxidase II (aTPOII); Atellica IM Anti-Thyroid Peroxidase II (aTPOII); Atellica IM aTPOII Quality Control (aTPOII QC); Atellica IM aTPOII Diluent (aTPOII DIL)
- Model identifier
- 11203694; 11206076; 11206077; 11206984; 11207637
- Registration date
- December 30, 2024
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 Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the Atellica® Analyzers. Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis.
Additional source fields
- Product owner address
- 511 Benedict Avenue, Tarrytown, NY 10591-5097, 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.