GTI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, Fluorescent, All Groups, N. Meningitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1
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 |
|---|---|---|
| DIRECTIGEN NEISSERIA MENINGITIDIS TEST (K920274) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-03-18 |
| DIRECTIGEN MENNINGITIS TEST KIT (K841308) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-02 |
Track GTI automatically
Every clearance here is in the API, with alerts when new ones post.