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Exact Diagnostics AMR Bundle

BKV Low Run Control
SKU:  BKVL101 

5 Vials, 1.0mL Fill Volume, -20°C Storage

LIMITATIONS:
For In Vitro Diagnostic Use.

​Product Insert - within United States
Safety Data Sheet
Certificate of Analysis  
​​
​   20020701
​
   21111101

Product Insert - outside United States


The EDX BKV Low Run Control has been calibrated against the 1st WHO International Standard for BK Virus, using digital PCR.  The EDX BKV Low Run Control is formulated using true EDTA plasma of the highest quality to ensure lot to lot reproducibility.

INTENDED USE:


EDX BKV Low Run Controls are a run control for various molecular assays, calibrated against the 1st WHO International Standard for BK Virus (14/212). The controls are used to monitor the presence of polyomavirus BK virus “BKV” DNA.  The control 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 BKV Low Run Controls are intact whole virus that has been heat inactivated. The control is intended to test the entire process of a variety of molecular assays from extraction, detection, and amplification.

The EDX BKV Low Run Controls are developed using heat inactivated BKV Virus and formulated in true EDTA plasma that was not found to be reactive for HBV DNA, BKV DNA, EBV DNA, HCV RNA, HIV-1 RNA, HBsAg, and antibodies for HIV-1/2, and HCV.

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