
Roche Diagnostic Systems, Inc.
Free shipping on orders over $99 · 30-day returns
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC is an FDA 510(k)-cleared medical device (K944231) manufactured by Roche Diagnostic Systems, Inc.. 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 December 1, 1994. Regulation: 8.