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Exact Diagnostics AMR Bundle

HIV AMR 
HIV-1 Analytical Measurement Range Panel
SKU:  HIVAMR

3 Panel Members, 600cp/mL, 60,000cp/mL, 6,000,000cp/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

   21040705 
​   22051816


Product Insert - outside United States


INTENDED USE:
The EDX HIV-1 Analytical Measurement Range (AMR) Panel is a standard for various molecular assays.  EDX HIV-1 AMR Panel is calibrated against the 3rd WHO International Standard for HIV-1 (10/152).  EDX HIV-1 AMR Panel is used to establish points of reference (qualitative and quantitative) for the measurement of Human Immunodeficiency Virus (HIV-1) RNA.  EDX HIV-1 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 HIV-1 Analytical Measurement Range Panel contains whole, intact virus that has been heat inactivated. EDX HIV-1 AMR panel is intended to test the entire process of a molecular assay including extraction, detection, and amplification. 

​The EDX HIV-1 AMR Panel is reported in copies per milliliter (cp/mL).  EDX HIV-1 AMR Panel is manufactured according to ISO 17511:2003.  EDX HIV-1 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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