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

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

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

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UltraQual® HBV PCR Assay – September 1, 2011:

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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