
Biomerieux Vitek, Inc.
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VIDAS DIGOXIN (DIG) is an FDA 510(k)-cleared medical device (K932250) manufactured by Biomerieux Vitek, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 9, 1993. Regulation: 8.