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Elecsys HBsAg II

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: ROCHE DIAGNOSTICS, INC.
Trade Name: Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 12/23/2016
Days to Decision: 175 days
Decision Code: APPR
FDA Decision: Approval