STN: BL 125361/23
Proper Name: Trypanosoma cruzi (T. cruzi)(E. coli, Recombinant) Antigen
Tradename: Abbott ESA Chagas
Manufacturer: Abbott Laboratories
- 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[ARCHIVED]
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