ORTHO T. cruzi ELISA Test System

Proper Name: Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen
Tradename: ORTHO T. cruzi ELISA Test System
Manufacturer: Ortho-Clinical Diagnostics, Inc, License #1236

Package Insert (PDF - 389 KB) - Approved: January 2009

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Date: February 18, 2009
Revision: Revise the package insert to include adding cadaveric specimens under the Intended Use section and changes to the Specimen Collection and Preparation section by adding Serum Separator Tube (SST) samples, elevated total protein, HAMA, and heterophilic antibodies specimens, as well as the addition of a new 192 test kit configuration.
February 18, 2009 Approval Letter

Date: December 13, 2006
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
December 13, 2006 Approval Letter
FDA Approves First Test to Screen Blood Donors for Chagas Disease - December 13, 2006
Summary Basis for Approval (PDF - 119 KB)