Product Name CARCINO-EMBRYONIC ANTIGEN -- (CEA) --
Product Code 10695B
Stage / Grade Partially Purified / Calibrator
R.M. Source Human Fluids
Concentration Range 0.5 - 5.0 mg/mL
Buffer Matrix & pH PBS with 0.1% NaN3 , pH: 7.4 (±0.2)
Optimal Storage Temperatures Less than 1 month; 4° C (± 3° C)
1 month to 36 mos.; -20° C to -30° C
Quality Control Methods / Results
Protein Quantitation Method ELISA microtiter assay correlated to Abbott AxSYM
Protein % Purity Range > 50 % (estimated by PAGE analysis)
Purification Method Affinity Purified
Known Contaminants Serum Proteins (Albumin, IgG)
Total Protein Method OD @ 280nm (1 cm light path)
Physical Characteristics
Color Amber to Colorless
Clarity Clear
Shelf Life 3 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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