Product code
OYM: Prostrate cancer genes nucleic acid amplification test system
FDA product code · Class III · Immunology
Key facts
| Product code | OYM |
|---|---|
| Device | Prostrate cancer genes nucleic acid amplification test system |
| Device class | Class III |
| Review panel | Immunology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 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