NOZ

Assay, 1,5-Anhydroglucitol (15ag)

Product code

NOZ

Device name

Assay, 1,5-Anhydroglucitol (15ag)

Device class

Class 2

21 CFR

21 CFR 864.7470

Medical specialty

Hematology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).