Product code
QFR: Coagulation system for the measurement of whole blood viscoelastic properties
FDA product code · Class II · Hematology
Key facts
| Product code | QFR |
|---|---|
| Device | Coagulation system for the measurement of whole blood viscoelastic properties |
| Device class | Class II |
| Regulation number | 864.5430 |
| Review panel | Hematology |
| Medical specialty | Hematology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients. |
At a glance
- 1–9 510(k) clearances
- 1–9 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