Product code
OEG: Autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230
FDA product code · Class II · Immunology
Key facts
| Product code | OEG |
|---|---|
| Device | Autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230 |
| Device class | Class II |
| Regulation number | 866.5660 |
| Review panel | Immunology |
| Medical specialty | Immunology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is intended as an aid in the diagnosis of bullous pemphigoid. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None 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