Product code QGU
- Device name
- Hemoglobin For Donor Testing
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7500
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Assays hemoglobin concentration test for blood donors.
- Source
- FDA openFDA device classification dataset