MIU
6 FDA 510(k) clearances · Product code
507 daysmedian time to decision
850 days90th percentile
6clearances measured
FDA profile
- Official device name
- Enzyme Linked Immunosorbent Assay, T. Cruzi
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3870
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2011: 13 · 2012: 7 · 2013: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Chagas Detect Plus Rapid Test (K161947) | InBios International, Inc. | 2016-12-16 |
| ORTHO T. CRUZI ELISA TEST SYSTEM (K072732) | Ortho-Clinical Diagnostics, Inc. | 2009-04-15 |
| WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (K023889) | Wiener Laboratories Saic | 2004-02-11 |
| HEMAGEN CHAGAS' KIT (EIA METHOD) (K930272) | Hemagen Diagnostics, Inc. | 1995-05-19 |
| ABBOTT CHAGAS ANTIBODY EIA (K933716) | Abbott Laboratories | 1994-12-19 |
| CHAGAS' IGG ELISA TEST (K911233) | Gull Laboratories, Inc. | 1992-05-04 |
Track MIU automatically
Every clearance here is in the API, with alerts when new ones post.