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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