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HIV-1 High Run Control   
SKU:  HIVH102 


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 

   21083004
    64512522


Product Insert - outside United States

The EDX HIV-1 High Run Controls have been calibrated against the WHO International Standard.  The EDX HIV-1 High Run Controls are formulated using True EDTA plasma of the highest quality to ensure lot-to-lot reproducibility.

INTENDED USE:
The EDX HIV-1 High Run Control is an external quality control, intended to be used with HIV-1 assays to monitor the performance of that given assay.  EDX HIV-1 High Run Control is calibrated against the 3rd WHO International Standard for HIV-1 (10/152).  EDX HIV-1 High Run Control is used to monitor the presence of Human Immunodeficiency Virus (HIV-1) RNA.  Routine use of EDX HIV-1 High Run Control allows laboratories to evaluate day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.     

PRODUCT DESCRIPTION:
The EDX HIV-1 High Run Control contains whole, intact virus that has been heat inactivated.  EDX HIV-1 High Run Control is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The EDX HIV-1 High Run Controls is formulated in True EDTA Plasma that was not found to be reactive for
HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2 and HCV.

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