Quality Control Methods / Results
Analyses:
- PURITY: > 95% by SDS PAGE. Single major 18 kDa
band corresponding to Tn-C.
- Total Protein: Determined by Bradford Assay using
BSA as reference standard.
Optimum Storage Conditions: -25°
C or below (Avoid repeated freeze thawing).
HAZARD TESTING &
WARNINGS:
Blood samples from tissue donors used in the manufacture
of this product have been tested at the donor level
for HBsAg, Anti-HIV-1/HIV-2, & HCV by FDA approved
methods and all results were non-reactive.
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. |
