HAZARD TESTING &
WARNINGS:
Serum Donor Units used in the manufacture of this product
were tested and found:
- Non-reactive for HBsAg by FDA approved Abbott -
Auszyme EIA
- Negative for Anti-HIV-1/HIV-2 by FDA approved Abbott
EIA procedure
- Negative for Anti-HCV by FDA approved Abbott HCV
EIA test
- Negative for HIV-1 Antigen(s) by FDA approved Abbott
EIA
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 or Remanufacture
of non-injectable products not subject to license under
PHS Act Section 351 only. |