STN: 125799
Proper Name: Elecsys Chagas
Tradename: Elecsys Chagas
Manufacturer: Roche Diagnostics
Indication: 

• Elecsys Chagas is an in vitro immunoassay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi, the causative agent of the Chagas disease) in human serum and plasma.
• Elecsys Chagas is intended to screen individual human donors, including volunteer donors of whole blood and blood components.
• The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.

Product Information

• Package Insert - Elecsys Chagas
• Package Insert - PreciControl Chagas
• Package Insert - PreciControl Release Chagas

Supporting Documents

• February 5, 2024 Approval Letter - Elecsys Chagas
• February 1, 2024 Summary Basis for Regulatory Action - Elecsys Chagas