C. ALBICANS/C. GLABRATA PNA FISH

C. ALBICANS/C. GLABRATA PNA FISH is an FDA 510(k)-cleared medical device (K092784) 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 March 11, 2010. Regulation: 8.