System for monitoring of monoclonal gammopathies in serum

nd result reporting (referred to as the "System"), as specified in section 3. Specification of requirements. The complete System, including the analytical method, must hold CE IVDR certification for the identification, measurement, and reporting of M-components (IgA, IgG, and IgM) in serum of patien

ts with multiple myeloma. Key technical criteria include automated sample processing and subsequent MALDI-ToF mass spectrometry to enable highly sensitive M-component identification in serum. The System must to be of the latest generation a