TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT

TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT is an FDA 510(k)-cleared medical device (K855046) manufactured by Abbott Laboratories. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 1986. Regulation: 8.