Multiple urine analyte IVD, kit, rapid colorimetric, self-testing

Definition
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].
GUDID devices
8
Last updated
2026-06-05 06:05:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860010249000Starling Medical, IncStarling Medical, Inc.DW-012052023-05-22
00860010249017Starling Medical, IncStarling Medical, Inc.DW-012062023-05-22
00860010249024Starling Medical, IncStarling Medical, Inc.DW-012072023-05-22
00860011489122Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.VI25V12024-11-25
00860015215833Vivoo At-Home UTI Test StripsVIVOSENS INC.VI26V22026-02-13
10860011489129Vivoo At-Home UTI Test StripsVIVOSENS INC.VI26V22026-02-13
00860011489146Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.VI25V12024-11-25
16976122480000LYZChangchun Lyz Technology Co., Ltd.100 strips 1 bottle2023-03-28