HSA · registration DE0510453Siemens Atellica CH Urine Albumin (UAlb)
SingaporeClinical chemistryClass BSiemens Healthcare Diagnostics Inc
Official record identity
- Registration number
- DE0510453
- Model name
- Atellica CH Urine Albumin (UAlb); Atellica CH Urine Albumin Calibrator (UAlb CAL)
- Model identifier
- 11537225; 11537247
- Registration date
- March 12, 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® CH Urine Albumin (UAlb) assay is for in vitro diagnostic use in the quantitative determination of albumin in human urine using the Atellica Analyzers. Measurement of albumin aids in the diagnosis of kidney diseases.
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.