Vaccines, Blood & Biologics
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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.
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Supporting Documents
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)
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Related Information
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.FDA approves first supplemental test for Chagas disease
Press Release: November 18, 2011
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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