Product code PEN
- Device name
- Gram-Negative Bacteria And Associated Resistance Markers
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3365
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
- Source
- FDA openFDA device classification dataset