
Ortho-Clinical Diagnostics, Inc.
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VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III is an FDA 510(k)-cleared medical device (K982649) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 11, 1998. Regulation: 8.