Product Approval Information

Proper Name: Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived)
Tradename: COBAS Ampliscreen HCV Test, version 2.0
Manufacturer: Roche Molecular Systems, Inc, License #1636

Package Insert (PDF - 453 KB) - Approved: May 22, 2007

Date: December 3, 2002
Indication: Dectecting HCV RNA, in conjunction with licensed tests for detecting antibodies to HCV
December 3, 2002 Approval Letter
Summary of Basis for Approval

Date: May 13, 2004
Indication: Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)
May 13, 2004 Approval Letter

Date: March 9, 2005
Indication: Testing of individual cadaveric specimens (obtained from non-heart-beating donors)
March 9, 2005 Approval Letter

Date: May 22, 2007
Changes in labeling, testing requirement, and increase in reagent refrigerator cycles
May 22, 2007 Approval Letter