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Discipline -
Haematology
Platelet count
Assay format
Automated haematology analyser
Information History
First added in 2019
Changed in 2020
Purpose type
Aid to diagnosis, Diagnosis
Purpose
To diagnose thrombocytopenia or thrombocytosis. Marker to manage severe infections associated with bleeding or sepsis (e.g. viral haemorrhagic fever, meningococcaemia) and certain haematological disorders.
Specimen types
Capillary whole blood, Venous whole blood
WHO prequalified or recommended products
N/A
GMDN
55860
Platelet count IVD, kit, cell count
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of platelet (thrombocyte) count in a clinical specimen using a manual, semi-automated or automated cell count 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
W0103010103
COMPLETE CELL COUNT
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
World Health Organization. (2017). WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262
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