Mass Spectrometry, Microorganism Identification, Blood Culture
The Mass Spectrometry Microorganism Identification device for Blood Culture is a microbiology diagnostic device that concentrates and purifies microbial cells from positive blood culture samples using associated reagents, with subsequent organism identification performed by mass spectrometry. It is intended for use with a continuous monitoring blood culture system. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3378 in the Microbiology specialty. It carries product code QNJ and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNJ
- Device Class
- FDA class 2
- Regulation Number
- 866.3378
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.