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U.S. Department of Health and Human Services

Product Classification

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Device aquaporin-4 autoantibody
Regulation Description Aquaporin-4 autoantibody immunological test system.
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.
Physical State Calibrators, Controls, and Assay Reagents
Technical Method Immunological detection of autoantibodies using capture antigen immobilized on solid surface and labeled secondary antibody
Target Area Whole blood, Plasma, and Serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePNI
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5665
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons