Point-of-care (POC) fluorescent immunoassay analyzer, reader

Primary use
Diagnosis / Measurement / Monitoring
Type of medical device or related product
Laboratory equipment
Multiple vs. specific use (health condition)
Multiple
Intended population age
All ages
Intended population sex
All
Level of technical knowledge
Specialized clinical
Capital
Yes
Reusable
Yes
Requirements
None
WHO list of priority medical devices
Cancer management (2017)
Cardiovascular diseases and diabetes (2021)
COVID-19 (2020)
Reproductive, maternal, newborn and child health (2015)
Service delivery platforms / Healthcare levels
First-level (district) hospital services
Second-level and third-level hospital services and specialized outpatient services
Healthcare unit
Laboratory
EMDN related code(s)
W0201069099
VARIOUS RAPID TEST CHEMISTRY/ IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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
GMDN related code(s)
48014
Fluorescent immunoassay analyser IVD, point-of-care (A portable, electrically-powered instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative, and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care and in the laboratory.)
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 2005-2025 
WHO related resources
Decommissioning
WHO resources on medical devices