PNI · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5665
Classification
FDA Product Code
PNI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5665
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.