QBX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Direct Blood Bacterial Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3960
- Medical specialty
- Microbiology
- FDA definition
- Amplification, detection and identification of microbial pathogens directly from whole blood specimens
- Adverse events (MAUDE)
- 2023: 17 · 2024: 31
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 |
|---|---|---|
| T2Bacteria® Panel (K233184) | T2biosystems, Inc. | 2024-02-08 |
| T2Bacteria Panel (K172708) | T2biosystems, Inc. | 2018-05-24 |
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Every clearance here is in the API, with alerts when new ones post.