Product code PNI— Immunology
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
- Classification name
- Aquaporin-4 Autoantibody
- Device class
- Class 2
- Regulation
- 21 CFR 866.5665
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
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.”
Market context for product code PNI
FDA has cleared devices under product code PNI, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PNI
Recent clearances under product code PNI
Data sourced from openFDA. This site is unofficial and independent of the FDA.