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Disease/health condition -
Kidney disease
Creatinine
Assay format
Optical methods on semi-automated or automated clinical chemistry analysers
Information History
First added in 2018
Changed in 2024
Purpose type
Determination of physiological status, Aid to diagnosis
Purpose
To assess kidney function through estimated glomerular filtration rate (eGFR), urine albumin:creatinine ratio (ACR), and urine protein:creatinine ratio. To aid in the diagnosis of kidney disease.
Specimen types
Serum, Urine
WHO prequalified or recommended products
N/A
GMDN
53251
Creatinine IVD, kit, spectrophotometry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen, using a spectrophotometry method.
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 2005-2024EMDN
W01010207
CREATININE
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/emdnWHO supporting publications
WHO list of priority medical devices for management of cardiovascular diseases and diabetes. (2021). https://iris.who.int/handle/10665/341967
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