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Elecsys Anti-HBc IgM

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: ROCHE DIAGNOSTICS CORP.
Trade Name: ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 12/14/2011
Days to Decision: 174 days
Decision Code: APPR
FDA Decision: Approval

FDA Browser

Elecsys Anti-HBc IgM

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: ROCHE DIAGNOSTICS CORP.
Trade Name: ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 12/14/2011
Days to Decision: 174 days
Decision Code: APPR
FDA Decision: Approval