Product Approval Information

Proper Name: Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived)
Tradename: COBAS AmpliScreen HBV Test
Manufacturer: Roche Molecular Systems, Inc, License No. 1636

Package Insert (PDF - 525 KB) - Approved: August 16, 2007

Date: April 21, 2005
Indication: Qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in human plasma from donations of Whole Blood and blood components for transfusion, and Source Plasma, as well as for testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)
April 21, 2005 Approval Letter
Summary of Basis for Approval (PDF - 197 KB)
Questions and Answers

Date: August 2, 2005
Indication: Testing for Hepatitis B Virus DNA in post-mortem cadaveric (non-heart-beating) donors using an individual testing format
August 2, 2005 Approval Letter

Date: August 16, 2007
Changes in the labeling, testing requirement, and an increase in reagent refrigerator cycles
August 16, 2007 Approval Letter