HSA · registration DE0510418Siemens CLINITEK Advantus Semi-Automated Urinalysis Analyzer
- Registration number
- DE0510418
- Model name
- CLINITEK Advantus Analyzer
- Model identifier
- 1420 (10484765)
- Registration date
- March 04, 2025
- Risk class
- Class B
- Product owner
- Siemens Healthcare Diagnostics Inc
- Registrant / registration holder
- SIEMENS HEALTHCARE PTE. LTD.
This analyzer is intended for the semi-quantitative and qualitative type of measurement of the following in human urine samples: Albumin, Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein- to-Creatinine ratio, Albumin-to-Creatinine ratio, specific gravity, and Urobilinogen. These measurements are used to aid in assessment of conditions such as: • Kidney disease • Urinary tract infections • Metabolic disorders, such as diabetes mellitus • Liver disease The analyzer is for professional use in centralized laboratory settings.
- Product owner address
- 511 Benedict Avenue, Tarrytown, NY 10591-5097, United States
- Registrant address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
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.