
Bd Diagnostics (Geneohm Sciences, Inc.)
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BD GENEOHM MRSA ACP ASSAY is an FDA 510(k)-cleared medical device (K093346) manufactured by Bd Diagnostics (Geneohm Sciences, 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 14, 2009. Regulation: 8.