Product code PBC
- Device name
- Manual Blood Grouping And Antibody Test Systems
- 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
- A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
- Source
- FDA openFDA device classification dataset