STN: 125090
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
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
• Testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)
   

Product Information

• Package Insert (PDF - 525 KB) - Approved: August 16, 2007- COBAS AmpliScreen HBV Test

Supporting Documents

• Supporting Documents older than three years - COBAS AmpliScreen HBV Test