PNI

Aquaporin-4 Autoantibody

Product code

PNI

Device name

Aquaporin-4 Autoantibody

Device class

Class 2

21 CFR

21 CFR 866.5665

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).