Test strip, urinalysis

Type of medical device or related product
General vs. specific use (health condition)
Intended population age
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
EMDN related code(s)
W0104010702
URINE SCREENING MANUAL - STRIPS, ETC.)
GMDN related code(s)
54514
Multiple 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.)