
Roche Diagnostics
Free shipping on orders over $99 · 30-day returns
COBAS U411 TEST SYSTEM is an FDA 510(k)-cleared medical device (K093555) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 1, 2010. Regulation: 8.