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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

FDA Browser

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