QBX — Direct Blood Bacterial Nucleic Acid Detection System Class II
FDA product code QBX covers "Direct Blood Bacterial Nucleic Acid Detection System", a Class II medical device regulated under 21 CFR 866.3960. 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
- QBX
- Device Class
- Class II
- Regulation Number
- 866.3960
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Amplification, detection and identification of microbial pathogens directly from whole blood specimens