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HSA · registration DE0510563

Sentinel Diagnostics Total Bile Acids Liquid

SingaporeClinical chemistryClass BSentinel CH. SpA
Official record identity
Registration number
DE0510563
Model name
Total Bile Acids Control Set; Total Bile Acids Liquid
Model identifier
1600201; 1700201
Registration date
April 07, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Clinical chemistry
Published parties
Product owner
Sentinel CH. SpA
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official description

The Total Bile Acids Liquid assay is intended for the enzymatic cycling colorimetric determination of total bile acids in serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use.

Additional source fields
Product owner address
Via Robert Koch 2, 20152 MILANO, Italy
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.