Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic kits designed to detect anti-Smith (anti-Sm) antibodies in patient specimens such as serum or plasma. These kits use an enzyme immunoassay (EIA) format to support the clinical assessment of autoimmune conditions, particularly systemic lupus erythematosus, by identifying the presence of autoantibodies associated with the Smith antigen.

Devices in this category are composed of reagents and associated materials intended for laboratory use in detecting anti-Sm antibodies via EIA methodology. They are regulated as in vitro diagnostic medical devices and are supplied as complete kits for qualitative and/or quantitative antibody detection in clinical laboratories.