
Roche Diagnostic Systems, Inc.
Free shipping on orders over $99 · 30-day returns
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL is an FDA 510(k)-cleared medical device (K964422) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 24, 1996. Regulation: 8.