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 Sebia, The Binding Site Group , Ltd. and The Binding Site, Ltd..
List of Kappa, Antigen, Antiserum, Control devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Kappa, Antigen, Antiserum, Control devices (product code DFH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →