Product code QBX
- Device name
- Direct Blood Bacterial Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3960
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Amplification, detection and identification of microbial pathogens directly from whole blood specimens
- Source
- FDA openFDA device classification dataset