Product code
PAQ: Test, nr2 antibody
FDA product code · Not Classified · Clinical Chemistry
Key facts
| Product code | PAQ |
|---|---|
| Device | Test, nr2 antibody |
| Device class | Not Classified |
| Review panel | Clinical Chemistry |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | NR2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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