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Medical Devices / Submissions and Approvals

FDA Approves Two Ortho Hepatitis B Assays

Sept. 19, 2017
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Ortho Clinical Diagnostics received FDA approval for its Vitros HBeAg and Anti-HBe assays for use with the company’s Vitros 5600 and 3600 systems.

Both assays are currently available on the Vitros ECi/ECiQ immunodiagnostic systems.

The assays are used to diagnose individuals with acute or chronic hepatitis B or in recovery from hepatitis B infection.

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