PNI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Aquaporin-4 Autoantibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5665
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (K161951) | Kronus, Inc. | 2016-07-22 | + Add |
| KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (DEN150030) | Kronus, Inc. | 2016-04-25 |
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