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U.S. Department of Health and Human Services

Product Classification

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Device assay, 1,5-anhydroglucitol (15ag)
Regulation Description Glycosylated hemoglobin assay.
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.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeNOZ
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible