Device typeImmunoglobulin M subclass (IgM subclass) IVD, reagent: A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple immunoglobulin M subclasses (IgM subclasses) in a clinical specimen.
FDA categoryIMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M)
Device IDM52592340
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information