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Synthetic Negative Run Control        
SKU:  NEGSYN


5 Vials, 1.0mL Fill Volume, -20°C Storage (24 months), 5 days at 2-8°C   
 
LIMITATIONS:
For In Vitro Diagnostic Use.    
      
Product Insert - within United States
Safety Data Sheet

Certificate of Analysis 
​   22050201

Product Insert - outside United States

INTENDED USE:
The Exact Diagnostics Synthetic Negative Run Control is a negative run control for various molecular assays. It is used to monitor the absence of Anaplasma phagocytophilum, Babesia microti, Bartonella quintana, Borrelia burgdorferi, Ehrlichia chaffeensis, Enterovirus (EV) Coxsackievirus A9, Herpes Simplex Virus-1 (HSV-1), Herpes Simplex Virus-2 (HSV-2), and Varicella Zoster Virus (VZV) in molecular assays. Routine use of the Exact Diagnostics Synthetic Negative Run Control allows laboratories to evaluate their molecular assay and test for operator proficiency. 

This product may also be utilized for dilution or spike-in purposes. 
              
PRODUCT DESCRIPTION:
The Exact Diagnostics Synthetic Negative Run Control is a formulated synthetic matrix intended to test the entire process of a molecular assay, including extraction, amplification and detection.  
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This product is non-reactive for Anaplasma phagocytophilum DNA, Babesia microti DNA, Bartonella quintana DNA, Borrelia burgdorferi DNA, Ehrlichia chaffeensis DNA, Enterovirus (EV) Coxsackievirus A9 RNA, Herpes Simplex Virus-1 (HSV-1) DNA, Herpes Simplex Virus-2 (HSV-2) DNA, and Varicella Zoster Virus (VZV) DNA. 


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