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bioMerieux, Inc.
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VIDAS B.R.A.H.M.S. PCT ASSAY is an FDA 510(k)-cleared medical device (K071146) manufactured by bioMerieux, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2007. Regulation: 8.