# MIU: Enzyme Linked Immunosorbent Assay, T. Cruzi

- Device class: 1; regulation: 21 CFR 866.3870; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1992: 1
- 1994: 1
- 1995: 1
- 2004: 1
- 2009: 1
- 2016: 1

## Most-cited predicates
- K023889: Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. NR. 1203254 (2004), cited by 1
- K930272: Hemagen Chagas' Kit (Eia Method) (1995), cited by 1

Source page: https://510kreport.com/product-code/MIU
Data by year (CSV): https://510kreport.com/product-code/MIU.csv