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Microphage, Inc.
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KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT is an FDA 510(k)-cleared medical device (K102342) manufactured by Microphage, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 4, 2011. Regulation: 8.