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Focus Diagnostics, Inc.
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PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M is an FDA 510(k)-cleared medical device (K073381) manufactured by Focus Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 3, 2008. Regulation: 8.