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Discipline -
Anatomical pathology
Cytopathological Examination
Assay format
Microscopic examination
Information History
First added in 2019
Changed in 2024
Purpose type
Diagnosis
Purpose
To assess cells for infection, neoplasia, inflammatory and degenerative disorders.
Specimen types
Urine, Body fluids (e.g., Cerebrospinal fluid, Pleural fluid, Peritoneal fluid), Body organs (e.g., Lymph node, Spleen, Cervix, Skin, etc), Bone marrow aspirate, Respiratory specimens (e.g., Sputum, Bronchial brushing, Bronchoalveolar lavage)
WHO prequalified or recommended products
N/A
GMDN
43587
Biological stain IVD
A chemical agent(s), dye(s) and/or solution(s) intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.
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
W1030708
STAIN SOLUTIONS (HISTOLOGY/CITOLOGY)
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. Regional Office for the Eastern Mediterranean. (2003). Basic histopathology and anatomical pathology services for developing countries with variable resources. https://iris.who.int/handle/10665/119675 ; World Health Organization. (2017). WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262 ; World Health Organization. (2019). Guide for establishing a pathology laboratory in the context of cancer control. World Health Organization. https://iris.who.int/handle/10665/330664
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