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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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COBAS AmpliScreen HBV Test

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

  • 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)

Supporting Documents