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
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)
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Supporting Documents
August 16, 2007 Approval Letter - COBAS AmpliScreen HBV
Changes in the labeling, testing requirement, and an increase in reagent refrigerator cyclesAugust 2, 2005 Approval Letter - COBAS AmpliScreen HBV
Testing for Hepatitis B Virus DNA in post-mortem cadaveric (non-heart-beating) donors using an individual testing formatApril 21, 2005 Approval Letter - COBAS AmpliScreen HBV Summary of Basis for Approval - COBAS AmpliScreen HBV Test (PDF - 197KB)Roche Molecular Systems COBAS Ampliscreen HBV Test Implementation Questions and Answers
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