Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic kits designed to detect anti-Jo-1 antibodies in patient samples using an enzyme immunoassay method. These tests are used clinically to support the diagnosis of autoimmune conditions such as polymyositis and dermatomyositis, where the presence of Jo-1 antibodies is a serological marker.

Devices in this category are regulated as in vitro diagnostic medical devices and are supplied as complete kits containing all necessary reagents and materials for performing the assay. They are intended for use by trained laboratory professionals in clinical settings and are not intended for self-testing or point-of-care use outside of a laboratory environment.