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Exact Diagnostics AMR Bundle

Borrelia Run Control    
SKU:  BORRC 

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

LIMITATIONS:
For In Vitro Diagnostic Use.
​
Product Insert - within United States
Safety Data Sheet
Certificate of Analysis
​   21112301
   64530138
 
 
Product Insert - outside United States

The EDX Borrelia Run Control has been value assigned using digital PCR.  The EDX Borrelia Run Control is formulated using Synthetic Matrix of the highest quality to ensure lot to lot reproducibility.

INTENDED USE:
The EDX Borrelia Run Control is an external quality control, intended to be used with Borrelia burgdorferi assays to monitor the presence of that given assay. The control is used to monitor the presence of Borrelia burgdorferi DNA.  Routine use of EDX Borrelia 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 Borrelia Run Control contains whole, intact organisms. The control is intended to test the entire process of a molecular assay including extraction, detection, and amplification.​

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