Device typePhotometric/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.
FDA categoryDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device ID00895160002014
Catalog numberNDT710
MRI safetyLabeling does not contain MRI Safety Information