Product code QBH
- Device name
- Lower Respiratory Microbial Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3985
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
- Source
- FDA openFDA device classification dataset