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ADVIA Centaur Anti-HBe2 (aHBe2) 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-HBe2 (aHBe2) assay
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
7/14/2021
Days to Decision
492 days
Decision Code
APPR
FDA Decision
Approval

ADVIA Centaur Anti-HBe2 (aHBe2) 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-HBe2 (aHBe2) assay
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
7/14/2021
Days to Decision
492 days
Decision Code
APPR
FDA Decision
Approval