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ADVIA CENTAUR ANTI-HBS ASSAY

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 ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
5/14/2004
Days to Decision
317 days
Decision Code
APWD
FDA Decision
Withdrawal after approval