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PMA application submitted for Vitros HIV Combo, 3/17

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March 2017—Ortho Clinical Diagnostics has submitted a premarket approval application to the U.S. Food and Drug Administration for the Vitros Immunodiagnostic Products HIV Combo Assay for use on the Vitros 3600 immunodiagnostic system. Ortho also submitted PMA supplements for the Vitros Immunodiagnostic Products HBeAg Assay and Vitros Immunodiagnostic Products Anti-HBe Assay for use on the Vitros 3600 system and Vitros 5600 integrated system.

Ortho Clinical Diagnostics, 800-828-6316

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