
Ortho-Clinical Diagnostics, Inc.
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VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS is an FDA 510(k)-cleared medical device (K121608) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 14, 2013. Regulation: 8.