Device typeMultiple urine analyte IVD, kit, rapid colorimetric, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.
FDA categoryBLOOD, OCCULT, COLORIMETRIC, IN URINE, DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT), INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.), METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE), TEST, URINE LEUKOCYTE
Device ID00682607200290
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information