Exact Diagnostics
  • ABOUT
  • CATALOG PRODUCTS
  • CUSTOM MANUFACTURING
  • CONTACT
Picture

HCV High Run Control       
SKU:  HCVH102 


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 
 
   20022807
   21083006
   64514779
​
​Product Insert - outside United States

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

INTENDED USE:
The EDX HCV High Run Control is an external quality control, intended to be used with HCV assays to monitor the performance of that given assay.  EDX HCV High Run Control is calibrated against the 4th WHO International Standard for Hepatitis C (06/102). The control is used to monitor the presence of Hepatitis C Virus (HCV) RNA.  Routine use of EDX HCV High Run Control allows laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.              

PRODUCT DESCRIPTION:
The EDX HCV High Run Control contains whole, intact virus.  EDX HCV High Run Control is developed using a recombinant, non-infectious virus which contains the HCV 5' UTR insertion. EDX HCV High Run Control is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The EDX HCV High Run Controls is formulated in True EDTA Plasma that is non-reactive for
HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2 and HCV.

View Product Catalog »

Home   |   ABOUT   |   CATALOG PRODUCTS   |   CUSTOM MANUFACTURING   |   CONTACT   |   PRIVACY POLICY   |  TErms of use


Picture
   © 2019 Exact Diagnostics LLC. All rights reserved.