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Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Trade Name: ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 1/20/2012
Days to Decision: 521 days
Decision Code: APPR
FDA Decision: Approval