Urine test strip colour chart IVD

Definition
A device in the form of a printed chart designed for the qualitative and semi-quantitative assessment of urine analyte (e.g., ketones, glucose, nitrites, leukocytes) concentration/pH by visually comparing urine test strip colour with a standard scale of colour variations that correlate with urine analyte concentration/pH. It is typically used to screen paediatric urine by clinicians in a healthcare facility or by laypersons in the home. This is a single-use device.
GUDID devices
11
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00025715232850Ezy DoseAPOTHECARY PRODUCTS, LLC232852020-11-16
00025715232973Ezy DoseAPOTHECARY PRODUCTS, LLC232972020-11-16
00025715669908Diabetic Specialty SolutionsAPOTHECARY PRODUCTS, LLC669902020-09-10
00860002060439Winx Health IncGet Stix Inc.12020-10-01
10884389181942MEDLINEMEDLINE INDUSTRIES, INC.MPHUA4OB2025-04-29
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.U021ST-URS-US2026-03-23
40884389181943MEDLINEMEDLINE INDUSTRIES, INC.MPHUA4OB2025-04-29
00850024942073StixGet Stix Inc.12020-10-01
00860002060484StixGet Stix Inc.12020-10-01
20025715669902Diabetic Specialty SolutionsAPOTHECARY PRODUCTS, LLC669902020-09-10
H65811271530Henry ScheinHENRY SCHEIN, INC.57013102019-05-24