Diagnostics

U.S. FDA grants clearance for hemoglobin A1c test

Published in Obesity and Diabetes Week, August 29th, 2005

Axis-Shield plc (ASD) announced that the Afinion System and its hemoglobin A1c (HbA1c) test for diabetes received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA).

Afinion is a multi-test system designed for use in physician office laboratories and hospital point-of-care (POC) sites. Axis-Shield has already introduced tests for Afinion HbA1c and Afinion CRP, which is used to distinguish between a viral and bacterial infection, in Europe.

Afinion's first test in the United States, HbA1c, will provide physicians with the ability to monitor glycemic control in patients with diabetes. The simple test procedure is fully...

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Source: Obesity and Diabetes Week (2005-08-29)

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