Product code
PFK: Quality control for molecular immunohematology tests
FDA product code · Class II · Pathology
Key facts
| Product code | PFK |
|---|---|
| Device | Quality control for molecular immunohematology tests |
| Device class | Class II |
| Regulation number | 864.9650 |
| Review panel | Pathology |
| Medical specialty | Hematology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None 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