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

Page Type

PMA Approval

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

FDA Browser

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

Page Type: PMA Approval
PDF: 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