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Discipline -
Clinical microbiology
Genus and species identification
Assay format
Automated systems
Information History
First added in 2020
Changed in 2024
Purpose type
Diagnosis
Purpose
To identify the genus and/or species of bacterial or fungal isolates.
Specimen types
Bacterial isolates, Fungal isolates
WHO prequalified or recommended products
N/A
GMDN
56743
Microorganism identification analyser IVD, automated/semi-automated
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens by characterizing their morphology, substrate utilization and/or biochemical reactivity, using growth detection technology which may include immunoassay, colorimetry, chromatography and/or carbon dioxide (CO2) production.
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
W01040801
BIOCHEMICAL IDENTIFICATION AND SUSCEPTIBILITY TESTING - AUTOMATED
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
Essential package of in vitro diagnostic tests for bacterial and fungal infections, and AMR. 2025. (To be published)
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