FDA product code QBX
Direct Blood Bacterial Nucleic Acid Detection System
Microbiology·Class 2·21 CFR 866.3960
US regulatory classifications
- US Product Code (FDA)
- QBXView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3960View CFR Regulation →
- Medical specialty
- Microbiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Amplification, detection and identification of microbial pathogens directly from whole blood specimens
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About this record
Direct Blood Bacterial Nucleic Acid Detection System is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.