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Discipline - Urinalysis
Urinalysis
Setting:
1. Non-laboratory
Tiered Testing Service:
Primary health care center without laboratory District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Dipstick
Information History
First added in 2018
Changed in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of urinary tract infections (UTIs) and kidney disease.
Specimen types
Urine
WHO prequalified or recommended products
N/A
GMDN

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)* . It is not intended to be used for self-testing.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
* e.g., leukocytes, blood, nitrites, proteins
EMDN

W0101060204

URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health. (2016). https://iris.who.int/bitstream/handle/10665/205490/9789241565028_eng.pdf?sequence=1
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte. It was recognized that the test is a foundational IVD test and is included in clinical guidelines.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A