Product approval information for use as a donor screening test to detect antibodies to hepatitis C virus in plasma and serum samples from individual human donors, including volunteer donors of Whole Blood, blood components, source plasma, and other living donors. It is also intended for use to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. This test is not intended for use on samples of cord blood.
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