Individual donor units in the preparation of this product have been tested by FDA approved tests and found to be non-reactive for HbsAg, Anti-HIV I/II, Anti-HCV, HIV-1 RNA, and HCV RNA. Donors of human plasma units used in making this product were tested and found negative for Syphilis according to FDA guidelines. CAUTION: FOR USE IN RESEARCH OR REMANUFACTURE OF NON-INJECTABLE PRODUCTS NOT SUBJECT TO LICENSE UNDER PHS ACT SECTION 351, ONLY.