Product code
PNI: Aquaporin-4 autoantibody
FDA product code · Class II · Immunology
Key facts
| Product code | PNI |
|---|---|
| Device | Aquaporin-4 autoantibody |
| Device class | Class II |
| Regulation number | 866.5665 |
| Review panel | Immunology |
| Medical specialty | Immunology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings. |
At a glance
- 1–9 510(k) clearances
- 1–9 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