
Ortho-Clinical Diagnostics, Inc.
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VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS is an FDA 510(k)-cleared medical device (K011250) 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 June 12, 2001. Regulation: 8.