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HBV High Run Control       
SKU:  HBVH102 


5 vials, 1.0mL, True EDTA Plasma, -20˚C Storage

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

   20030502
   21081705
   22051202


Product Insert - outside United States

The EDX HBV High Run Controls have been calibrated against the WHO International Standard.  The EDX HBV High Run Controls are formulated using True EDTA plasma of the highest quality to ensure lot-to-lot reproducibility.

INTENDED USE:
The EDX HBV High Run Control is an external quality control, intended to be used with HBV assays to monitor the performance of that given assay.  EDX HBV High Run Control is calibrated against the 3rd WHO International Standard for Hepatitis B (10/264). The control is used to monitor the presence of Hepatitis B Virus (HBV) DNA.  Routine use of EDX HBV High Run Control allows laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.           

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

The EDX HBV Low Run Control 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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