Device typeUrine analyser IVD, point-of-care: A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care 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, AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.), BLOOD, OCCULT, COLORIMETRIC, IN URINE, DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT), DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.), Dye-indicator, pH (urinary, non-quantitative), ENZYMATIC METHOD, CREATININE, INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.), METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE), NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.), REFRACTOMETER FOR CLINICAL USE, TEST, URINE LEUKOCYTE
Device ID20682607200911
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information