Vaccines, Blood & Biologics
COBAS AmpliScreen HCV Test
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: Detecting HCV RNA, in conjunction with licensed tests for detecting antibodies to HCV
December 3, 2002 Approval Letter
Summary of Basis for Approval (PDF - 82 KB)
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
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448