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ARCHITECT CORE-M / Alinity i Anti-HBc IgM

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: Abbott Laboratories
Trade Name: ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 11/6/2007
Days to Decision: 340 days
Decision Code: APPR
FDA Decision: Approval