Device typeChemiluminescent immunoassay 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 (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.
FDA categoryTest, equipment, automated bloodborne pathogen
Device ID00380740156817
Catalog number04R7050
MRI safetyLabeling does not contain MRI Safety Information