Aptiva Celiac Disease IgA Reagent

Aptiva Celiac Disease IgA Reagent is an FDA 510(k)-cleared medical device (K193604) manufactured by Inova Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2021. Regulation: 8.