GILFORD IMMUNOGLOBULIN A REAGENT

GILFORD IMMUNOGLOBULIN A REAGENT is an FDA 510(k)-cleared medical device (K853467) manufactured by Gilford. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 1985. Regulation: 8.