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bioMerieux, Inc.
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VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 is an FDA 510(k)-cleared medical device (K040882) manufactured by bioMerieux, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 2004. Regulation: 8.