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Discipline - Haematology
Body fluids analysis
Assay format
Microscopic examination
Information History
First added in 2020
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of inflammatory, infectious and neoplastic diseases involving body fluids (e.g. pleural, peritoneal, synovial, pericardial, CSF) by detecting the presence or absence of cells (white blood cells, red blood cells, mesothelial cells) along with white blood cell total count and differential count.
Specimen types
Body fluids (e.g., Cerebrospinal fluid, Pleural fluid, Peritoneal fluid)
WHO prequalified or recommended products
N/A
GMDN

43673

Microscope counting chamber IVD

A counting chamber intended to be used for the microscopic enumeration of cells, cellular particles, or other biological components present in clinical laboratory specimens.

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
EMDN

W01030103

CELLULAR STAINS FOR MICROSCOPY

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
World Health Organization. (‎2017)‎. WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262 ; 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