Device typeMultiplex analyser IVD, laboratory: An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software.
FDA categoryInstrumentation for clinical multiplex test systems
Device ID00840487100363
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information