Definition: For The Semi-quantitative Measurement Of IgG Class Autoantibodies Against Mutated Citrullinated Vimentin (MCV) In Human Serum Or Plasma.
| Device Type ID | 3089 |
| Device Name | Anti-mutated Citrullinated Vimentin Igg |
| Physical State | Antigen Coated Microtiter Wells, Calibrators, Controls, Enzyme Conjugate And Substrate, Buffer |
| Technical Method | Enzyme Immunoassay (ELISA) |
| Target Area | Serum Or Plasma |
| Regulation Description | Rheumatoid Factor 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 | 866.5775 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |