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 An
| Device Type ID | 3106 |
| Device Name | Aquaporin-4 Autoantibody |
| 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 Description | Aquaporin-4 Autoantibody Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5665 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3106 |
| Device | Aquaporin-4 Autoantibody |
| Product Code | PNI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Aquaporin-4 Autoantibody Immunological Test System. |
| CFR Regulation Number | 866.5665 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |