Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay

This category includes in vitro diagnostic kits designed to detect one or more antibodies linked to systemic lupus erythematosus (SLE) in patient samples. These kits use a fluorescent immunoassay method to support the clinical assessment of SLE, an autoimmune condition where the immune system attacks healthy tissues.

Devices in this category are reagent-based test systems intended for use in clinical laboratories. They are regulated as in vitro diagnostic medical devices and are supplied as complete kits containing all necessary components for performing the assay, following the fluorescent immunoassay principle described in the reference definition.