
Thermo Fisher Scientific
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The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) is an FDA 510(k)-cleared medical device (K143526) manufactured by Thermo Fisher Scientific. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 4, 2015. Regulation: 8.

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