Device typeUrine analyser IVD, laboratory: An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.
FDA categoryAutomated Urinalysis System, Refractometer For Clinical Use
Device ID15099590811761
AvailabilityPrescription
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information