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ARCHITECT HBsAg Qualitative/Confirmatory / Alinity i HBsAg Qualitative II/Confirmatory

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: Abbott Laboratories
Trade Name: ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 4/12/2012
Days to Decision: 261 days
Decision Code: APPR
FDA Decision: Approval