Product code
NRP: Sirolimus test system
FDA product code · Class II · Toxicology
Key facts
| Product code | NRP |
|---|---|
| Device | Sirolimus test system |
| Device class | Class II |
| Regulation number | 862.3840 |
| Review panel | Toxicology |
| Medical specialty | Toxicology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 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