
Ortho-Clinical Diagnostics, Inc.
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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS is an FDA 510(k)-cleared medical device (K032993) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 30, 2003. Regulation: 8.