
Roche Diagnostics Operations (Rdo)
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ONLINE TDM Vancomycin Gen.3 is an FDA 510(k)-cleared medical device (K152245) manufactured by Roche Diagnostics Operations (Rdo). This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 7, 2016. Regulation: 8.