STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3

STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 is an FDA 510(k)-cleared medical device (K963346) manufactured by Consolidated Technologies, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 8, 1996. Regulation: 8.