BD MAX MRSA ASSAY, BD MAX INSTRUMENT

BD MAX MRSA ASSAY, BD MAX INSTRUMENT is an FDA 510(k)-cleared medical device (K120138) 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 July 4, 2012. Regulation: 8.