GTH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1993: 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 |
|---|---|---|
| BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT (K900546) | Baxter Healthcare Corp | 1990-06-15 |
| MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST (K861835) | Syva Co. | 1986-05-29 |
| NEISSERIA GONORRHOEAE FLUORO-KIT (K800328) | Clinical Sciences, Inc. | 1980-03-03 |
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Every clearance here is in the API, with alerts when new ones post.