QZX
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1650
- Medical specialty
- Microbiology
- FDA definition
- Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PBC Separator with Selux AST System (K244044) | Selux Diagnostics, Inc. | 2025-03-28 |
| PBC Separator with Selux AST System (K223493) | Selux Diagnostics, Inc. | 2024-02-15 |
| eQUANT System (K231536) | Avails Medical, Inc. | 2024-02-08 |
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Every clearance here is in the API, with alerts when new ones post.