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          Procleix Babesia AssayVaccines, Blood & Biologics Procleix Babesia Assay
  
  	
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    Print**STN#** 125673**Proper Name:** Procleix Babesia Assay**Tradename:** Procleix Babesia Assay**Manufacturer:** Grifols Diagnostic Solutions, Inc.**Indication:**

The Procleix Babesia Assay is a qualitative *in vitro* nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.**Product Information**

Package Insert - Procleix Babesia Assay**Supporting Documents**

November 20, 2020 Approval Letter - Procleix Babesia Assay
	February 12, 2020 Approval Letter - Procleix Babesia Assay
	January 24, 2019 Approval Letter – Procleix Babesia Assay
	January 18, 2019 Summary Basis of Regulatory Action - Procleix Babesia Assay

                                                                                  Content current as of:
      12/09/2021
              
              
Regulated Product(s)
		 BiologicsVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
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          Vaccines
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