Product code PEO
- Device name
- Fungal Organisms, Nucleic Acid-Based Assay
- 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 fungal organisms in positive blood cultures.
- Source
- FDA openFDA device classification dataset