OCN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Insulin Autoantibody Kit
- 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 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT (K070183) | Kronus Market Development Associates, Inc. | 2007-07-13 | + Add |
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