QNJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mass Spectrometry, Microorganism Identification, Blood Culture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3378
- Medical specialty
- Microbiology
- FDA definition
- Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Accelerate Arc System (K240854) | Accelerate Diagnostics, Inc. | 2024-09-26 |
| MBT Sepsityper (K193419) | Bruker Daltonik GmbH | 2020-12-27 |
Track QNJ automatically
Every clearance here is in the API, with alerts when new ones post.