Product code
NOZ: Assay, 1,5-anhydroglucitol (15ag)
FDA product code · Class II · Hematology
Key facts
| Product code | NOZ |
|---|---|
| Device | Assay, 1,5-anhydroglucitol (15ag) |
| Device class | Class II |
| Regulation number | 864.7470 |
| Review panel | Hematology |
| Medical specialty | Hematology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database