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Exact Diagnostics AMR Bundle

HCV Verification Panel, 1.4mL
SKU:  HCVP200

7 Panel Members, 1.4mL, -20˚C Storage
Dynamic Range 100IU/mL - 30,000,000IU/mL

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LIMITATIONS:
For In Vitro Diagnostic Use.

Product Insert - within United States
Safety Data Sheet
Certificate of Analysis
    21042101
    21080331 


Product Insert - outside United States
 

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

INTENDED USE:

EDX HCV Verification Panel is a standard for various molecular assays, calibrated against the 4th WHO International Standard for Hepatitis C (06/102). The verification panel is used to measure the presence (qualitative and quantitative) of Hepatitis C virus “HCV” RNA.  The materials are whole, intact virus allowing operators to test the entire process of a molecular assay, train operators and test for proficiency.

PRODUCT DESCRIPTION:

EDX HCV Verification Panel is intact whole virus that is non-infectious. The verification panel is intended to test the entire process of a variety of molecular assays from extraction, detection, and amplification.
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EDX HCV Verification Panel is reported in International Units per milliliter (IU/mL).  The verification panel members are developed using a recombinant virus containing the HCV 5’ UTR insertion. The EDX HCV Verification Panel is formulated in EDTA plasma that was found to be non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg, anti-HCV, and anti-HIV-1/2.

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