Product Name BREAST TUMOR ANTIGEN  -- (CA15-3) --
Product Code 10672B
Stage / Grade Partially Purified / Low Cross Reactivity
R.M. Source Human Fluids
Concentration Range 5,000 to 80,000 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 Ca 27.29  RIA Assay
Protein % Purity Range 300 to 20,000 U/mL/ OD @ 280nm
Quality Methods Contaminants measured by CIS-ELSA 19-9 and
Centocor CA-125 RIA; U/mL/OD @ 280nm
Allowable Contaminants (type & level) Contains < 25% CA19-9, CA-125
Total Protecin Acceptable Range 1-50 OD
Total Protein Method OD @ 280nm
Physical Characteristics
Color Amber to green
Clarity Clear to turbid
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.
TriChem Resources, Inc.
909 Old Fern Hill Road, Suite 2, West Chester, PA 19380, USA
T: 1-610-431-3529 | Fax: 1-610-436-9370 | E: info@trichemresources.com
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