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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, 1,5-anhydroglucitol (15ag)
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.
Product CodeNOZ
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1

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