Urine analyser IVD, point-of-care

A urine analyser IVD, point-of-care is a mains-powered instrument designed for use by healthcare professionals at the point of care to perform in vitro testing of urine samples. It qualitatively and/or quantitatively measures multiple chemical and cellular components such as glucose, protein, blood, pH, nitrites, leukocytes, and microorganisms to support the diagnosis and monitoring of conditions like urinary tract infections, diabetes, and kidney disorders.

Devices in this category are regulated as in vitro diagnostic medical devices and are typically supplied as standalone analysers or integrated systems requiring compatible test strips or cartridges. They rely on technologies including photometry, enzyme-based assays, conductivity, and nephelometry to generate results, and are intended for professional use in clinical settings such as clinics, emergency departments, or outpatient facilities where rapid urine testing is needed.