EBV Verification Panel       
SKU:  EBVP100 

5 Panel Members, 1.0mL Fill Volume, -20°C Storage, Dynamic Range 500IU/mL-5,000,000IU/mL

LIMITATIONS:
For In Vitro Diagnostic Use.
    
Product Insert - within United States
Safety Data Sheet
Certificate of Analysis
​   19121302
​   21101806

Product Insert - outside United States
The EDX EBV Verification Panel has been calibrated against the WHO 1st International Standard, using digital PCR.  The panel offers a wide dynamic range.  The EDX EBV Verification Panel is formulated using True EDTA plasma of the highest quality to ensure lot to lot reproducibility.

INTENDED USE:
The EDX EBV Verification Panel is a standard for various molecular assays.  EDX EBV Verification Panel is calibrated against the 1st WHO International Standard for Epstein-Barr Virus (09/260).  EDX EBV Verification Panel is used to establish points of reference (qualitative and quantitative) of Epstein-Barr Virus (EBV) DNA.  EDX EBV Verification Panel allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The EDX EBV Verification Panel contains whole, intact virus that has been heat inactivated.  EDX EBV Verification Panel is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The EDX EBV Verification Panel is reported in International Units per milliliter (IU/mL).  EDX EBV Verification is value assigned by digital droplet PCR and manufactured according to ISO 17511:2013.  EDX EBV Verification Panel is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, EBV DNA, HBsAg, and antibodies for HIV-1 and 2, and HCV.
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