Singapore HSA registration DE0509613
Siemens Atellica CH Aspartate Aminotransferase P5P (ASTPLc)
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered August 02, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509613
- Registration Date
- August 02, 2024
- Retention Due Date
- August 01, 2025
Product 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.
Product Owner
- Short Name
- Siemens Healthcare, USA
- Address
- 511 Benedict Avenue, Tarrytown, NY 10591, UNITED STATES
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- Atellica CH Aspartate Aminotransferase P5P (ASTPLc) Atellica CH ENZ 2 Calibrator (ENZ 2 CAL)
- Model Identifier(s)
- 11097639 11099318
About this record
Access comprehensive regulatory information for Siemens Atellica CH Aspartate Aminotransferase P5P (ASTPLc) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509613 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on August 02, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD