VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS is an FDA 510(k)-cleared medical device (K042303) 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 September 26, 2004. Regulation: 8.