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VITROS Anti-HBe

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: ORTHO-CLINICAL DIAGNOSTICS
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 7/20/2011
Days to Decision: 537 days
Decision Code: APPR
FDA Decision: Approval