
Roche Diagnostic Systems, Inc.
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ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE is an FDA 510(k)-cleared medical device (K893856) 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 August 2, 1989. Regulation: 8.