NOZ — Assay, 1,5-Anhydroglucitol (15ag) Class II
FDA product code NOZ covers "Assay, 1,5-Anhydroglucitol (15ag)", a Class II medical device regulated under 21 CFR 864.7470. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NOZ
- Device Class
- Class II
- Regulation Number
- 864.7470
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- 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.