VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS is an FDA 510(k)-cleared medical device (K012561) manufactured by Ortho-Clinical Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 28, 2001. Regulation: 8.