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Bd Diagnostics (Geneohm Sciences Canada, Inc)
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BD GENEOHM STAPHSR ASSAY is an FDA 510(k)-cleared medical device (K071026) manufactured by Bd Diagnostics (Geneohm Sciences Canada, 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 December 19, 2007. Regulation: 8.