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    1. / Home
    2. / Relevant FDA Documents

    UltraQual® Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV – May 2018:

    Download BLA Approval PDF(Opens in a new window) View the Assay


    UltraQual® HCV RT-PCR Assay – September 18, 2001:

    View the Assay View the Assay


    UltraQual® HIV RT-PCR Assay – September 18, 2001:

    View the Assay


    UltraQual® HBV PCR Assay – September 1, 2011:

    View the Assay Download BLA Approval PDF(Opens in a new window)

    Relevant FDA Documents

    CFR - Code of Federal Regulations Title 21; Section 610.40

    CFR - Code of Federal Regulations Title 21; Section 610.67

    CFR - Code of Federal Regulations Title 21; Section 630.15

    CFR - Code of Federal Regulations Title 21; Section 630.25

    CFR - Code of Federal Regulations Title 21; Section 640.65

    CFR - Code of Federal Regulations Title 21; Section 640.120

    Regulations Title 21; Chapter I; Subchapter F

    Blood Guidances @ FDA 

    FDA List of Donor Screening Assays for Infectious Agents    

    Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

    NAT Testing Guidance Document for HIV-1 and HCV

     

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