NWG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autoantibodies, Glutamic Acid Decarboxylase (Gad)
- 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 glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT (K072135) | Kronus Market Development Associates, Inc. | 2007-11-07 |
| KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT (K051061) | Kronus Market Development Associates, Inc. | 2005-11-04 |
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