Product code
PBC: Manual blood grouping and antibody test systems
FDA product code · Class II · Hematology
Key facts
| Product code | PBC |
|---|---|
| Device | Manual blood grouping and antibody test systems |
| Device class | Class II |
| Regulation number | 864.9175 |
| Review panel | Hematology |
| Medical specialty | Hematology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database