Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic test kits designed to detect one or more antibodies linked to coeliac disease in patient samples. These kits use an enzyme immunoassay method to screen for markers such as anti-gliadin, anti-endomysial, anti-IgA, or anti-tissue transglutaminase antibodies, aiding in the clinical assessment of coeliac disease.

Devices in this category are supplied as complete reagent kits for laboratory use and are regulated as in vitro diagnostic medical devices. They are intended for professional use in clinical laboratories and must meet performance and safety requirements for diagnostic testing, though specific regulatory classifications vary by jurisdiction.