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

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

View the Assay View the Assay

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

UltraQual® HBV PCR Assay – September 1, 2011:

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