HBV AMR 
HBV Analytical Measurement Range Panel
SKU:  HBVAMR

3 Panel Members, 100IU/mL, 100,000IU/mL, 10,000,000IU/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
   18110276
​   21071315

Product Insert - outside United States
  

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INTENDED USE:
The EDX HBV Analytical Measurement Range (AMR) Panel is a standard for various molecular assays.  EDX HBV AMR Panel is calibrated against the 3rd WHO International Standard for Hepatitis B (10/264). EDX HBV AMR Panel is used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis B Virus (HBV) DNA.  EDX HBV 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 HBV AMR Panel contains whole, intact virus that has been heat inactivated. EDX HBV AMR panel is intended to test the entire process of a molecular assay including extraction, detection, and amplification.
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The EDX HBV AMR Panel is reported in International Units per milliliter (IU/mL).  EDX HBV AMR Panel is manufactured according to ISO 17511:2003.  EDX HBV 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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