GNE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Latex Agglutination, T. Cruzi
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3870
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DAT TEST FOR CHAGAS' DISEASE (K834328) | Sero-Immuno Diagnostics, Inc. | 1984-03-02 |
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Every clearance here is in the API, with alerts when new ones post.