Definition: The Device Is Used For The Semi-quantitative Determination Of Autoantibodies Against Tyrosine Phosphatase (IA-2) In Human Serum As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes).
| Device Type ID | 3083 |
| Device Name | Tyrosine Phosphatase (ia-2) Autoantibody Assay |
| Physical State | N/a |
| Technical Method | Radioimmunoassay |
| Target Area | N/a |
| Regulation Description | Multiple Autoantibodies 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 | 866.5660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OIF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3083 |
| Device | Tyrosine Phosphatase (ia-2) Autoantibody Assay |
| Product Code | OIF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| CFR Regulation Number | 866.5660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |