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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Supporting Documents
February 18, 2009 Approval Letter
Revise the package insert to include adding cadaveric specimens under the Intended Use section and changes to the Specimen Collection and Preparation sectionDecember 13, 2006 Approval Letter Trypanosoma cruzi (T. cruzi) (Anti- T. cruzi Assay) - ORTHO T. cruzi ELISA Test System - Summary of Basis for Approval (PDF - 118KB)
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Related Information
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.FDA Approves First Test to Screen Blood Donors for Chagas Disease
Press Release: December 13, 2006
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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
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