Product Approval Information
Proper Name: Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5)
Tradename: ABBOTT PRISM HCV
Manufacturer: Abbott Laboratories, License #0043
Package Insert (PDF - 357 KB) - July, 2007
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Date: July 11, 2007
Indication: For the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens
July 11, 2007 Approval Letter
Summary of Basis for Approval (PDF - 113 KB)