QNJ — Mass Spectrometry, Microorganism Identification, Blood Culture Class II
FDA product code QNJ covers "Mass Spectrometry, Microorganism Identification, Blood Culture", a Class II medical device regulated under 21 CFR 866.3378. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.