Device typeMultiple monoclonal immunoglobulin isotype IVD, kit, mass spectrometric immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple monoclonal immunoglobulin isotypes including IgA, IgG, IgM, and may also include kappa and lambda light chains, in a clinical specimen, using a mass spectrometric immunoassay method. It is typically used to aid in the diagnosis and monitoring of monoclonal gammopathies such as multiple myeloma, Waldenström's disease, and macroglobulinaemia.
FDA categoryMass Spectrometric, Immunoglobulins (G, A, M, D, E)
Device ID05051700021050
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information