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VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

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-HCV REAGENT PACK AND CALIBRATOR
Generic Name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date: 8/30/2001
Days to Decision: 150 days
Decision Code: APPR
FDA Decision: Approval

FDA Browser

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

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-HCV REAGENT PACK AND CALIBRATOR
Generic Name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision Date: 8/30/2001
Days to Decision: 150 days
Decision Code: APPR
FDA Decision: Approval