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VITROS Anti-HBe

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Trade Name
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
7/20/2011
Days to Decision
537 days
Decision Code
APPR
FDA Decision
Approval