PNI · Class II · 21 CFR 866.5665

FDA Product Code PNI: Aquaporin-4 Autoantibody

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.

Leading manufacturers include Kronus, Inc..

2
Total
1
Cleared
153d
Avg days
2016
Since

FDA 510(k) Cleared Aquaporin-4 Autoantibody Devices (Product Code PNI)

2 devices
1–2 of 2
Cleared Jul 22, 2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
K161951
Kronus, Inc.
Immunology · 7d
Not Cleared Apr 25, 2016
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
DEN150030
Kronus, Inc.
Immunology · 298d

About Product Code PNI - Regulatory Context