Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic kits designed to detect one or more extractable nuclear antigens (ENA) in patient samples using an enzyme immunoassay method. These tests are used clinically to support the diagnosis and monitoring of autoimmune diseases such as systemic lupus erythematosus and Sjögren’s syndrome by identifying autoantibodies against nuclear proteins.

Devices in this category are supplied as kits containing reagents and associated materials for laboratory use. They are regulated as in vitro diagnostic medical devices and are intended for professional use in clinical laboratories to perform qualitative or quantitative screening of ENA markers.