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Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Trade Name
ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
1/20/2012
Days to Decision
521 days
Decision Code
APPR
FDA Decision
Approval

Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Trade Name
ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
1/20/2012
Days to Decision
521 days
Decision Code
APPR
FDA Decision
Approval