Immunoassay analyzer, POC

Type of medical device or related product
Multiple vs. specific use (health condition)
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
Healthcare unit
EMDN related code(s)
W020102
IMMUNOCHEMISTRY INSTRUMENTS
GMDN related code(s)
42625
Photometric/spectroscopic immunoassay analyser IVD (An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle 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 the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] at the point-of-care or in the laboratory.)
Related WHO Essential in vitro diagnostic test