
Ortho-Clinical Diagnostics
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VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS is an FDA 510(k)-cleared medical device (K030067) 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 January 16, 2003. Regulation: 8.