QNJ — Mass Spectrometry, Microorganism Identification, Blood Culture Class II
Classification Details
- Product Code
- QNJ
- Device Class
- Class II
- Regulation Number
- 866.3378
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.