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VITROS Anti-HBc IgM

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: Ortho-Clinical Diagnostics, Inc.
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 3/4/2004
Days to Decision: 251 days
Decision Code: APPR
FDA Decision: Approval

FDA Browser

VITROS Anti-HBc IgM

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: Ortho-Clinical Diagnostics, Inc.
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 3/4/2004
Days to Decision: 251 days
Decision Code: APPR
FDA Decision: Approval