IDI-MRSA ASSAY

IDI-MRSA ASSAY is an FDA 510(k)-cleared medical device (K042357) manufactured by Infectio Diagnostic (I.D.I.), 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 October 21, 2004. Regulation: 8.