HAZARD TESTING & WARNINGS:
All donor materials used in the manufacture of this product have been tested and found negative for HBsAg, HIV1/2 Ab, and HCV Ab by FDA approved methods. Samples from donor units are non-reactive for HIV-1, HCV, and HBV by Nucleic Acid Tests (NAT) run according to FDA recommendations.
CAUTION: NO TEST CAN GUARANTEE A PRODUCT TO BE NON-INFECTIOUS. THEREFORE, ALL MATERIAL DERIVED FROM HUMAN FLUIDS OR TISSUES SHOULD BE CONSIDERED AS POTENTIALLY INFECTIOUS.
Use Statement: For use in Research, Remanufacturing, or Immunization use for products not subject to license under PHS Act Section 351 only.