Direct Blood Bacterial Nucleic Acid Detection System
The Direct Blood Bacterial Nucleic Acid Detection System is an in vitro diagnostic device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens, used to rapidly diagnose bloodstream infections without requiring culture. It is classified as a Class 2 device under regulation 866.3960, requiring 510(k) premarket notification, and falls within the Microbiology (MI) medical specialty. The product code is QBX. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBX
- Device Class
- FDA class 2
- Regulation Number
- 866.3960
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Amplification, detection and identification of microbial pathogens directly from whole blood specimens
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.