HBV Verification Panel       
SKU:  HBVP100 

7 Panel Members, 1.0mL, -20˚C Storage 
Dynamic Range 100IU/mL - 100,000,000IU/mL

LIMITATIONS:
For In Vitro Diagnostic Use. 
    
Product Insert - within United States
Safety Data Sheet
Certificate of Analysis
​   21010622
​   21052808

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

INTENDED USE:
The EDX HBV Verification Panel is a standard for various molecular assays.  EDX HBV Verification Panel is calibrated against the 3rd WHO International Standard for Hepatitis B (10/264).  EDX HBV Verification Panel is used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis B Virus (HBV) DNA.  EDX HBV Verification Panel allows laboratories to evaluate their molecular assay and test for operator proficiency.
       
PRODUCT DESCRIPTION:
The EDX HBV Verification Panel contains whole, intact virus that has been heat inactivated. EDX HBV Verification Panel is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The EDX HBV Verification Panel is reported in International Units per milliliter (IU/mL).  EDX HBV Verification Panel is manufactured according to ISO 17511:2003.  EDX HBV Verification Panel is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2 and HCV.

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