Device typeNephelometry 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 in a clinical specimen using an immunological method which utilizes a nephelometric detection system to determine the rate and/or quantity of particle agglutination occurring through the formation of immune complexes, together with sample processing, data processing and/or data display software.
FDA categoryIGG, ANTIGEN, ANTISERUM, CONTROL
Device ID00630414002903
Catalog numberOVIA112
MRI safetyLabeling does not contain MRI Safety Information