Product code PNI

Device name

Aquaporin-4 Autoantibody

Medical specialty

Immunology

Device class

2

Regulation number

866.5665

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset