Product Name OVARIAN CANCER ANTIGEN  -- (CA-125) --
Product Code 10640B
Stage / Grade Highly Purified / Antigen
R.M. Source Human Fluids
Concentration Range 50,000 to 200,000 U/mL
Buffer Matrix & pH PBS Buffer with 0.1% Sodium Azide
pH: 7.4 (± 0.2)
Optimal Storage Temperatures 4° C short term; -20° C long term
Quality Control Methods / Results
Protein Quantitation Method Centocor RIA CA-125 Assay
Protein % Purity Range No bands on PAGE with 1000 Unit load;
Relative purity ratio: > 50,000 [U/mL ÷ OD280]
Quality Methods SDS PAGE (reduced) Electrophoresis:
no bands; 1000 Unit load / Coomassie stain
Western blot (diffuse band ~ 200kDa with
Centocor Mab)
Allowable Contaminants (type & level) No major serum protein contaminants, and
contains < 25% CA19-9, CA15-3
Total Protecin Acceptable Range 0.05 mg/mL - 20.0 mg/mL
Total Protein Method OD @ 280nm
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 donor unit level for HBsAg, Anti-HIV-1/HIV-2, HIV-1 Antigen, & HCV in Abbott EIA - FDA registered assays 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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