NGS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Endotoxin Activity, Chemiluminescent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3210
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2013: 8
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 |
|---|---|---|
| Endotoxin Activity Assay (EAA) (K183176) | Spectral Medical, Inc. | 2019-03-12 |
| ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (DEN030002) | Spectral Diagnostics, Inc. | 2003-06-16 |
Track NGS automatically
Every clearance here is in the API, with alerts when new ones post.