E.COLI/P. AERUGINOSA PNA FISH

E.COLI/P. AERUGINOSA PNA FISH is an FDA 510(k)-cleared medical device (K081309) manufactured by Advandx, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 18, 2008. Regulation: 8.