Product Name C-REACTIVE PROTEIN ANTIGEN -- (CRP) --
Product Code 10520A
Stage / Grade Partially Purified / Calibrator-Control
R.M. Source Human Fluids
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 using CRM 470 IFC reference standard
Protein % Purity Range > 70%
Quality Methods Used Purity ratio = CRP conc. (mg/mL) ÷ Total protein
Allowable Contaminants (type & level) Serum Proteins (Albumin, IgG); up to 30%
Total Protein Acceptable Range 1.5 - 7.1 mg/mL
Total Protein Method OD units (280nm) ÷ 1.7 mg/mL/OD units
Physical Characteristics
Color Slight amber to 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, & 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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