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Ortho-Clinical Diagnostics, Inc.
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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is an FDA 510(k)-cleared medical device (DEN210038) 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 May 4, 2023. Regulation: 8.
