FDA Product Code DFH: Kappa, Antigen, Antiserum, Control

Under FDA product code DFH, kappa antigen antisera and controls are cleared for use in immunophenotyping of lymphoproliferative disorders.

These reagents detect kappa light chain expression on B lymphocytes and plasma cells by immunohistochemistry or flow cytometry. Assessment of kappa/lambda light chain ratio is used to identify monoclonal immunoglobulin production in multiple myeloma and B-cell lymphomas.

DFH devices are Class II medical devices, regulated under 21 CFR 866.5550 and reviewed by the FDA Immunology panel.

Leading manufacturers include Amico Lab, Inc., The Binding Site, Ltd. and Siemens Healthcare Diagnostics Products GmbH.