
Ortho-Clinical Diagnostics, Inc.
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VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS is an FDA 510(k)-cleared medical device (K041322) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 2004. Regulation: 8.