Vaccines, Blood & Biologics

ORTHO T. cruzi ELISA Test System

STN: BL 125161
Proper Name: Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen
Tradename: ORTHO T. cruzi ELISA Test System
Manufacturer: Ortho-Clinical Diagnostics, Inc
Indication:

  • Donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of whole blood, blood components or source plasma, and other living donors. It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating
     

 

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Food and Drug Administration

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Silver Spring, MD 20993-0002

Page Last Updated: 12/02/2014
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