NOZClass II
Assay, 1,5-anhydroglucitol (15ag)
Hematology · 21 CFR 864.7470
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.
MDR events0All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
2 clearances for this product code