Product code OQX
- Device name
- Self-Contained Blood Grouping
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9175
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended for single use for individual blood group determination for educational and informational purposes
- Source
- FDA openFDA device classification dataset