XPERT MRSA/SA BLOOD CULTURE ASSAY

XPERT MRSA/SA BLOOD CULTURE ASSAY is an FDA 510(k)-cleared medical device (K082140) manufactured by Cepheid. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 2008. Regulation: 8.