Product Name C-REACTIVE PROTEIN ANTIGEN -- (CRP) --
Product Code 10524A
Stage / Grade Highly Purified / Immunogen Grade
R.M. Source Human Plasma (collected from US-FDA licensed facilities)
Concentration Range 1.5 - 5.0 mg/mL
Buffer Matrix & pH 0.1M Tris, 0.2M NaCl, 2mM CaCl2, 0.1% NaN3 pH: 7.5 (± 0.2)
Optimal Storage Temperatures Less than 4 months; 4° C (± 3° C)
4 mos. to 24 mos. ; -20° C to -30° C
Quality Control Methods / Results
Protein Quantitation Method RID referenced to Beckman Array and CRM 470 IFC standard
Protein % Purity Range > 95% by PAGE Analysis
Quality Methods Used SDS-PAGE (reduced) Electrophoresis;
single band @ 21kDa; IEP vs GAH whole serum
Allowable Contaminants (type & level) Minor to none; <5%
Specificity Positive identity on IEP using monospecific GAH CRP Ab
Total Protein Method OD units (280nm) ÷ 1.7 mg/mL/OD units
Physical Characteristics
Color Colorless
Clarity Clear
Shelf Life 2 years at -20° C
Filtration 0.2 µm filtered

HAZARD TESTING & WARNINGS:

Donor units used in the manufacture of this product were tested and found:

  1. Non-reactive for HBsAg by FDA approved Abbott - Auszyme EIA
  2. Negative for Anti-HIV-1/HIV-2 (rDNA) by FDA approved Abbott EIA procedure
  3. Negative for Anti-HCV by FDA approved Abbott HCV EIA 2.0 test
  4. Negative for HIV-1 Antigen(s) by FDA approved Abbott EIA
  5. Negative for Serological test for Syphilis by FDA approved ASI RPR Latex agglutination test

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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