Device typeMultichannel 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 multiple chemical and/or biological markers in a clinical specimen. The analyser typically includes sample processing, requires analyte specific test kits or reagents, and incorporates multiple channels using two or more immunological methods which may include chromatographic or electrochemical separation, together with enzyme, fluorescent, chemiluminescent, nephelometric, radiometric, electrometric and/or photometric detection systems.
FDA categoryApparatus, Automated Blood Cell Diluting
Device ID08800021900172
Single useYes
MRI safetyLabeling does not contain MRI Safety Information