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PNIClass II

Aquaporin-4 Autoantibody

21 CFR 866.5665 / Immunology
FDA source (opens on fda.gov)

PNI is the FDA product code for Aquaporin-4 Autoantibody, a class II device type, regulated under 21 CFR 866.5665. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PNI
Device name
Aquaporin-4 Autoantibody
FDA 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.
Regulation
21 CFR 866.5665
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PNI

By decision year
2 clearances under product code PNI with a decision year between 2016 and 2016, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PNI by decision year
YearClearances
20162

Applicants with the most clearances

Product code PNI
Applicants holding the most 510(k) clearances under product code PNI
ApplicantClearances
Kronus, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code