Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components: Guidance for Industry

Issue Date: December 5, 2017
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components: Guidance for Industry

We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. These recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device.

Download the Guidance Document

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