
Ortho-Clinical Diagnostics, Inc.
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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS is an FDA 510(k)-cleared medical device (K060678) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2006. Regulation: 8.