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Assay, 1,5-Anhydroglucitol (15ag)

FDA product code NOZ · 2 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.7470
Review panel
HE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2003-09-22 – 2018-10-04

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.

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