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 categoryAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric), Automated 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), Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), Method, Enzymatic, Glucose (Urinary, Non-Quantitative), Nitroprusside, Ketones (Urinary, Non-Quant.), Solution, Copper Sulfate For Specific Gravity Determinations, Test, Urine Leukocyte
Device ID06935740751797
Single useYes
MRI safetyLabeling does not contain MRI Safety Information