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Atellica IM Anti-Hepatitis B core Total (HBcT) 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 HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
12/22/2004
Days to Decision
327 days
Decision Code
APPR
FDA Decision
Approval

Atellica IM Anti-Hepatitis B core Total (HBcT) 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 HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
12/22/2004
Days to Decision
327 days
Decision Code
APPR
FDA Decision
Approval