Product Name CRP CONTROL (C-Reactive Protein) --
Product Code 10528A
Stage / Grade Control
R.M. Source Human Fluids and/or Serum
Concentration Range Prepared to Customer Specifications
Buffer Matrix & pH NHS (Normal Human Serum) in:0.1M Tris, 0.2M NaCl, 2mM CaCl2, 0.1% Sodium Azide, 15ppm Proclin (pH: 7.5)
Optimal Storage Temperatures 4° C short term -20° C long term
Quality Control Methods / Results
Protein Quantitation Method RID referenced to Behring standard (Protein standards may be supplied by customer)
Total Protein Method OD @ 280nm (1 cm light path)
Physical Characteristics
Color Amber
Clarity Clear
Shelf Life (from manufacture date) 18 months @ 4° C
> 18 mos. to 48 months; Store Frozen at -20° C
Filtration 0.2 µm filtered

HAZARD TESTING & WARNINGS:

Serum 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 by FDA approved Abbott EIA procedure
  3. Negative for Anti-HCV by FDA approved Abbott HCV EIA test
  4. Negative for HIV-1 Antigen(s) by FDA approved Abbott EIA

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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