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In this section: Vaccines, Blood & Biologics

COBAS AmpliScreen HBV Test

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

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