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Ortho-Clinical Diagnostics
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VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III is an FDA 510(k)-cleared medical device (K042494) manufactured by Ortho-Clinical Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2004. Regulation: 8.