Kappa/lambda light chain immunoglobulin IVD, antibody

Kappa/lambda light chain immunoglobulin in-vitro diagnostic (IVD) devices are laboratory tests designed to detect and measure specific light chains (kappa or lambda) in patient samples. Clinically, these tests help diagnose and monitor conditions like multiple myeloma, monoclonal gammopathy, and other plasma cell disorders by identifying abnormal protein levels in blood or urine.

These devices are typically regulated as IVD reagents or kits, often requiring compliance with standards for analytical performance and clinical safety. They are commonly supplied as ready-to-use reagents, monoclonal or polyclonal antibodies, or assay components for use in clinical laboratories, with classification varying by jurisdiction based on risk and intended use.