
Biomerieux Vitek, Inc.
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VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY is an FDA 510(k)-cleared medical device (K921816) manufactured by Biomerieux Vitek, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 17, 1992. Regulation: 8.