Vaccines, Blood & Biologics
ABBOTT ESA Chagas
STN: BL 125361/23
Proper Name: Trypanosoma cruzi (T. cruzi)(E. coli, Recombinant) Antigen
Tradename: Abbott ESA Chagas
Manufacturer: Abbott Laboratories
Indication: The assay is intended for use as an additional, more specific test on human serum or plasma specimens found to be repeatedly reactive using a licensed screening test for antibodies to T. cruzi.
November 18, 2011 Approval Letter - ABBOTT ESA Chagas
To include an in vitro enzyme strip assay intended for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum and plasma specimens.
Summary Basis for Regulatory Action - ABBOTT ESA Chagas(PDF - 191KB)
FDA Online Label Repository
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FDA approves first supplemental test for Chagas disease[ARCHIVED]
Press Release: November 18, 2011