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ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
Trade Name
ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
5/26/2005
Days to Decision
545 days
Decision Code
APPR
FDA Decision
Approval