Aquaporin-4 Autoantibody
The Aquaporin-4 Autoantibody (product code PNI) is a Class 2 immunology in vitro diagnostic device intended for the determination of autoantibodies to Aquaporin-4 in human serum and plasma as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD), regulated under 866.5665. The test is not to be used alone and must be interpreted in conjunction with clinical and radiological (MRI) laboratory findings. It requires 510(k) clearance and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- PNI
- Device Class
- FDA class 2
- Regulation Number
- 866.5665
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.