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Atellica IM Hepatitis B e Antigen (HBeAg) Assay

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: SIEMENS HEALTHCARE DIAGNOSTICS
Trade Name: ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 10/11/2011
Days to Decision: 719 days
Decision Code: APPR
FDA Decision: Approval