Product code
QHT: Reagent red blood cells
FDA product code · Unclassified · Hematology
Key facts
| Product code | QHT |
|---|---|
| Device | Reagent red blood cells |
| Device class | Unclassified |
| Regulation number | 660.30 |
| Review panel | Hematology |
| Medical specialty | Hematology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For the detection of or identification of human blood-group antibodies |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 100–999 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