OIF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tyrosine Phosphatase (Ia-2) Autoantibody Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K220085) | Kronus, Inc. | 2023-08-24 |
| KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K171731) | Kronus, Inc. | 2018-01-19 |
| KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (K073590) | Kronus Market Development Associates, Inc. | 2008-04-10 |
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Every clearance here is in the API, with alerts when new ones post.