Device typeMultiple urine analyte IVD, kit, rapid colorimetric, self-testing: 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 test is intended to be used for self-testing by a layperson in the home or similar environment to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins].
FDA categoryDiazo (Colorimetric), Nitrite (Urinary, Non-Quant), Test, Urine Leukocyte
Device ID00860011489122
AvailabilityOver the counter
Single useYes
MRI safetyLabeling does not contain MRI Safety Information