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Meridian Bioscience, Inc.
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IMMUNOCARD STAT! E. COLI O157 PLUS is an FDA 510(k)-cleared medical device (K023599) manufactured by Meridian Bioscience, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 2, 2003. Regulation: 8.