Product code
QBG: Assay, oral direct thrombin inhibitor
FDA product code · Not Classified · Hematology
Key facts
| Product code | QBG |
|---|---|
| Device | Assay, oral direct thrombin inhibitor |
| Device class | Not Classified |
| Review panel | Hematology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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