GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED

GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED is an FDA 510(k)-cleared medical device (K861000) manufactured by Ciba Corning Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 2, 1986. Regulation: 8.