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Exact Diagnostics AMR Bundle

HCV AMR 
HCV Analytical Measurement Range Panel
SKU:  HCVAMR

3 Panel Members, 500IU/mL, 50,000IU/mL, 5,000,000IU/mL, 1.0mL Fill Volume, -20˚C Storage 

LIMITATIONS:
For In Vitro Diagnostic Use.

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

   21012214
   64532753
Product Insert - outside United States


INTENDED USE:
The EDX HCV Analytical Measurement Range (AMR) Panel is a standard for various molecular assays.  EDX HCV AMR Panel is calibrated against the 4th WHO International Standard for Hepatitis C (06/102).  EDX HCV AMR Panel is used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis C Virus (HCV) RNA.  EDX HCV AMR Panel allows laboratories to evaluate the analytical measurement range of their molecular assay, test for operator proficiency, and perform calibration verification.

PRODUCT DESCRIPTION:
The EDX HCV AMR Panel contains whole, intact virus. EDX HCV AMR panel is developed using recombinant, non-infectious virus which contains the HCV 5' UTR insertion.  EDX HCV AMR Panel is intended to test the entire process of a molecular assay including extraction, detection, and amplification.
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The EDX HCV AMR Panel is reported in International Units per milliliter (IU/mL).  EDX HCV AMR Panel is manufactured according to ISO 17511:2003.  EDX HCV AMR 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, HIV-2, and HCV.


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