GMN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigens, Cf, 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 |
|---|---|---|
| TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (K894261) | Microbix Biosystems, Inc. | 1989-10-16 |
| TOXOPLASMA GONDII (K864981) | Virion (U.S.), Inc. | 1987-10-30 |
| AGGLUTINOTEST-TOXOPLASMOSIS (K791456) | Volu Sol Medical Industries | 1979-09-24 |
Track GMN automatically
Every clearance here is in the API, with alerts when new ones post.