NPO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3045
- Medical specialty
- Microbiology
- FDA definition
- A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| REDLINE ANTHRAX ALERT TEST (K030370) | Tetracore, Inc. | 2003-12-09 |
Track NPO automatically
Every clearance here is in the API, with alerts when new ones post.