HSA · registration DE0509613Siemens Atellica CH Aspartate Aminotransferase P5P (ASTPLc)
SingaporeClinical chemistryClass BSiemens Healthcare Diagnostics Inc
Official record identity
- Registration number
- DE0509613
- Model name
- Atellica CH Aspartate Aminotransferase P5P (ASTPLc); Atellica CH ENZ 2 Calibrator (ENZ 2 CAL)
- Model identifier
- 11097639; 11099318
- Registration date
- August 02, 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® CH Aspartate Aminotransferase P5P (ASTPLc) assay is for in vitro diagnostic use in the quantitative determination of aspartate aminotransferase activity in human serum and plasma (lithium heparin) on the Atellica® Analyzer. This assay is used to aid in the diagnosis and treatment of certain types of liver and heart disease.
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.