IMMUNOCARD STAT! E. COLI O157:H7

IMMUNOCARD STAT! E. COLI O157:H7 is an FDA 510(k)-cleared medical device (K990263) manufactured by Meridian Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 8, 1999. Regulation: 8.