Gull Laboratories Inc. said that the FDA granted marketingapproval to its diagnostic test kit for Chagas' disease.
The disease, caused by an infection with the protozoan parasiteTrypanosoma cruzi, is often transmitted by blood transfusion.It is a major health problem in Latin America for children andyoung adults, with severe cases frequently leading to death byheart failure, the Salt Lake City company said. Acute cases havebeen diagnosed in the U.S. and Canada, Gull said.
The Chagas IgG ELISA test is part of the company's series ofcolor-controlled ELISA tests for infectious diseases.
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