QUIDEL TOTAL IGE POSITIVE CONTROL SERUM

QUIDEL TOTAL IGE POSITIVE CONTROL SERUM is an FDA 510(k)-cleared medical device (K905162) manufactured by Quidel Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 1991. Regulation: 8.