Product code NOZ

Device name

Assay, 1,5-Anhydroglucitol (15ag)

Medical specialty

Hematology

Device class

2

Regulation number

864.7470

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset