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Elecsys Anti-HBc IgM

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: ROCHE DIAGNOSTICS CORP.
Trade Name: ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 1/3/2012
Days to Decision: 158 days
Decision Code: APPR
FDA Decision: Approval