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Vaccines, Blood & Biologics

February 18, 2009 Approval Letter - ORTHO T. cruzi ELISA Test System

February 18, 2009

Our STN: BL 125161/23

Ortho-Clinical Diagnostics, Inc.
Attention: Laura C. Vellucci, Ph.D.
1001 US Highway 202
Raritan , NJ 08869

Dear Dr. Vellucci:

We have approved your request to supplement your biologics license application for Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen to 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.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (three for circulars and other labels).

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

--- signature ---

Hira L. Nakhasi, Ph.D.
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research

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