Product Approval Information
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 - 373 KB) - Approved: December 13, 2006
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)