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Elecsys HBeAg

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: ROCHE DIAGNOSTICS OPERATIONS INC
Trade Name: ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 3/14/2014
Days to Decision: 288 days
Decision Code: APPR
FDA Decision: Approval