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Elecsys HBsAg Immunoassay

Page Type: PMA Approval
PDF: FDA Hosted PDF
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Applicant: ROCHE DIAGNOSTICS CORP.
Trade Name: ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 6/1/2001
Days to Decision: 820 days
Decision Code: APWD
FDA Decision: Withdrawal after approval