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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