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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448