Siemens CLINITEK Status+ Semi-Automated Urinalysis Analyzer - HSA Registration DE0510417
Access comprehensive regulatory information for Siemens CLINITEK Status+ Semi-Automated Urinalysis Analyzer 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 DE0510417 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on March 04, 2025.
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.
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.