SCRIPPSERA ANA REFERENCE CONTROL SERA

SCRIPPSERA ANA REFERENCE CONTROL SERA is an FDA 510(k)-cleared medical device (K810081) manufactured by Scripps-Miles, 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 February 8, 1981. Regulation: 8.