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Atellica IM Hepatitis B core IgM (aHBcM) Assay

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: SIEMENS HEALTHCARE DIAGNOSTICS
Trade Name: ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 8/6/2004
Days to Decision: 330 days
Decision Code: APPR
FDA Decision: Approval