2d3bb3b5-8619-4dc5-aca6-298b5112f9c1NewPublished12024-10-242024-10-16In Commercial Distribution06974246461663PrimaryGS1Welcheck URINARY TRACT INFECTION TEST3 testsUTI-1021544349634Safecare Biotech (Hangzhou) Co., Ltd.1falsetruefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse54514Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA 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.falseActiveLJXTest, Urine Leukocytefalsefalse