Product Name ALPHA-FETOPROTEIN ANTIGEN -- (AFP) --
Product Code 10610B
Stage / Grade Affinity Purified / Cell Culture Derived
R.M. Source Cell Culture
Concentration Range 0.5 - 5.0 mg/mL
Buffer Matrix & pH 0.1M Tris, 0.2M NaCl, 0.1% NaN3 , pH: 7.5 (±0.2)
Optimal Storage Temperatures Less than 3 months; 4° C (± 3 C°)
3 mos. to 24 mos.; -20° C to -30° C
Quality Control Methods / Results
Protein Quantitation Method DPC AFP Double Antibody RIA
Protein % Purity Range > 95%; no reactivity on IEP with anti-NHS
Quality Methods SDS-PAGE Electrophoresis, IEP vs GAH whole serum
Allowable Contaminants (type & level) None or minor serum proteins
Specificity Reactivity with DPC MAb on Western Blot
Total Protein Method OD @ 280nm / 0.53  (1 cm light path)
Physical Characteristics
Color Colorless
Clarity Clear
Shelf Life 2 years at -20° C
Filtration 0.2 µm filtered

HAZARD TESTING & WARNINGS:

Raw materials used in the manufacture of this product have been tested at the Human cell line supernate level for HBsAg, Anti-HIV-1/HIV-2, & HCV in an Abbott FDA registered assay 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.

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