
Roche Diagnostics Operations (Rdo)
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TOTAL PROTEIN URINE/CSF GEN.3 is an FDA 510(k)-cleared medical device (K141925) manufactured by Roche Diagnostics Operations (Rdo). This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 8, 2014. Regulation: 8.