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HSA · registration DE0510417

Siemens CLINITEK Status+ Semi-Automated Urinalysis Analyzer

SingaporeClinical chemistryClass BSiemens Healthcare Diagnostics Inc
Official record identity
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
Classification
Risk class
Class B
Official value: CLASS B
Published category
Clinical chemistry
Published parties
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official description

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.

Additional source fields
Product owner address
511 Benedict Avenue, Tarrytown, NY 10591-5097, 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.