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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 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