Assay, 1,5-Anhydroglucitol (15ag)
The 1,5-anhydroglucitol (15AG) assay is a hematology in vitro diagnostic test that provides quantitative measurement of 1,5-anhydroglucitol in patient blood samples for professional use in monitoring glycemic control in people with diabetes. It is classified as FDA Class 2 under regulation 864.7470 in the Hematology specialty, requiring 510(k) premarket notification. Product code NOZ is not eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NOZ
- Device Class
- FDA class 2
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.