LLA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Direct Agglutination Test, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- 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 |
|---|---|---|
| TOXOGEN (K913467) | Biokit USA, Inc. | 1993-01-11 |
| QUIK-DOT TOXOPLASMOSIS (K890048) | Ampcor, Inc. | 1989-06-09 |
| TOXOSCAN CARD TEST KIT (K850768) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-05-20 |
| TOXO-SCREEN DA TEST (K831930) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-26 |
Track LLA automatically
Every clearance here is in the API, with alerts when new ones post.