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FDA-approved Ortho hepatitis B assays, 11/17

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November 2017—Ortho Clinical Diagnostics received FDA approval for the Vitros Immunodiagnostic Products HBeAg Assay and the Vitros Anti-HBe Assay for use on the Vitros 3600 Immunodiagnostic System and 5600 Integrated System.

Both assays are used as an aid to diagnose hepatitis B infection in individuals with acute or chronic hepatitis B or recovery from hepatitis B infection. They are currently available in the U.S. on the Vitros ECi/ECiQ immunodiagnostic systems.

Ortho Clinical Diagnostics, 800-828-6316

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