Download

Discipline - Clinical chemistry
Blood gases
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Blood gas analyser
Information History
First added in 2018
Changed in 2024
Purpose type
Determination of physiological status
Purpose
To assess lung function, metabolic or kidney disorders and monitor oxygen therapy.
Specimen types
Arterial whole blood
WHO prequalified or recommended products
N/A
GMDN

52858

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

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

W01010606

ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC

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
WHO list of priority medical devices for management of cardiovascular diseases and diabetes. (2021). https://iris.who.int/handle/10665/341967
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