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Id Biomedical Corp.
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VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE is an FDA 510(k)-cleared medical device (K020576) manufactured by Id Biomedical Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2002. Regulation: 8.