Siemens CLINITEK Status+ Semi-Automated Urinalysis Analyzer
- Registration number
- DE0510417
- Model name
- CLINITEK Status+ Analyzer; CLINITEK Status Connector
- Model identifier
- 10379676; 11537761
- Registration date
- March 04, 2025
- Source update date
- July 30, 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: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein- to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). 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 • Pregnancy The CLINITEK Status+ analyzer is intended for professional use in near patient (point-of-care) facilities and centralized laboratory locations.
- Product owner address
- 511 Benedict Avenue, Tarrytown, NY 10591-5097, United States
- Registrant address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
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