GRT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antiserum, Fluorescent, Mycobacterium Tuberculosis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3370
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1 · 2009: 3
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 |
|---|---|---|
| AGGLUTINOTEST-TUBERCULOSIS (K791452) | Volu Sol Medical Industries | 1979-09-24 |
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Every clearance here is in the API, with alerts when new ones post.