Insulin Autoantibody Kit
Device Code: 3081
Product Code(s):
OCN Definition: The Device Is Used For The Semi-quantitative Determination Of Insulin Autoantibodies In Human Serum As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes) In Patients Who Have Not Received Insulin Therapy.
Device Classification Information
| Device Type ID | 3081 |
| Device Name | Insulin Autoantibody Kit |
| Physical State | Not Applicable |
| Technical Method | Immunoassay |
| Target Area | Not Applicable |
| 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 | OCN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3081 |
| Device | Insulin Autoantibody Kit |
| Product Code | OCN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| CFR Regulation Number | 866.5660 [🔎] |
TPLC Last Update: 2019-04-02 20:23:33