Product approval information is intended for:
• Use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
• Use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors.
• Use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma.
• Used in conjunction with licensed tests for detecting antibodies to HIV-1, HCV, and hepatitis B core antigen (anti-HBc), and with licensed tests for hepatitis B surface antigen (HBsAg).
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