Product Approval Information
Proper Name: Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA)
Tradename: CHIRON RIBA HCV 3.0 Strip Immunoblot Assay
Manufacturer: Novartis Vaccines and Diagnostics, Inc, License #1751
Package Insert (PDF - 1.9 MB) - Approved: February 11, 1999
Date: February 11, 1999
Indication: Strip Immunoblot Assay including NS5 and c33c recombinant proteins and c100p, 5-1-1p and c22p synthetic peptides to detect antibodies to Hepatitis C Virus in human serum or plasma
February 11, 1999 Approval Letter
Summary of Basis for Approval (PDF - 1.7 MB)