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Discipline - Immunohematology
Blood crossmatching
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Tube agglutination test
Information History
First added in 2018
Changed in 2024
Purpose type
Screening
Purpose
To determine blood compatibility for blood transfusions.
Specimen types
Capillary whole blood, Venous whole blood, Serum
WHO prequalified or recommended products
N/A
GMDN

45811

Polyspecific antihuman globulin IVD, antibody

One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies fixed to red blood cells and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin, using an agglutination or solid-phase red blood cell adherence 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 2005-2024
EMDN

W0103030304

POLYSPECIFIC ANTIHUMAN SERUM

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
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