Product Name CARCINO-EMBRYONIC ANTIGEN -- (CEA) --
Product Code 10690B
Stage / Grade Highly Purified / Antigen
R.M. Source Human Fluids
Concentration Range 1.0 - 5.0 mg/mL
Buffer Matrix & pH PBS with 0.1% NaN3 , pH: 7.4 (±0.2)
Optimal Storage Temperatures Up to 1 month; 4° C (± 3° C)
1 month to 18 mos.; -20° C to -30° C
Quality Control Methods / Results
Protein Quantitation Method EIA referenced to Abbott AxSYM
Protein % Purity Range > 95% purity by SDS-PAGE (non-reduced) Electrophoresis
Product Quality / Methods Used Western Blot (single 180 kDa band).
< 25% CEA Ag concentration in Truquant 27-29 RIA Assay, Centocor CA19-9 RIA Assay, & Centocor CA-125 RIA Assay
Purity Ratio; CEA mg/mL ÷ OD280nm (100)
Lot Specificity Positive Western Blot using anti-CEA Monoclonal Ab
Total Protein OD @ 280nm (1 cm light path); < 5.2 OD Units
Physical Characteristics
Color Colorless
Clarity Clear
Shelf Life 18 months 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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