Device typeEnzyme immunoassay (EIA) analyser IVD: An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids.
FDA categoryFluorometer, For Clinical Use
Device ID04560189282896
MRI safetyLabeling does not contain MRI Safety Information