Product code
OWD: Somatic gene mutation detection system
FDA product code · Class III · Immunology
Key facts
| Product code | OWD |
|---|---|
| Device | Somatic gene mutation detection system |
| Device class | Class III |
| Review panel | Immunology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 10–99 PMA approvals
- 1–9 HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 10–99 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