Aventis plasma-derived products
Executive Summary
Labeling for Monoclate-P, Mononine, Gammar-P I.V., Albuminar-5, Albuminar-20 and Albuminar-25 has been revised to note that the plasma-derived products have undergone polymerase chain reaction testing for viruses. The new labeling states that "the plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1, by an investigation test procedure referred to as nucleic acid testing (NAT) using polymerase chain reaction (PCR) technology"