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EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care business, announces that its Quo-Test analyser has received US Food and Drug Administration 510(k) clearance for professional use in a clinical laboratory setting.

The Quo-Test is a fully automated glycated haemoglobin (HbA1c) analyser, providing fast, easy and reliable HbA1c measurement for the monitoring and management of diabetes.

The FDA 510(k) clearance allows the Quo-Test to be used in a laboratory setting for in-vitro quantitative determination of HbA1c in whole blood samples. 

For more information on the Quo-Test see: https://www.ekfdiagnostics.com/quo-test.html

Commenting, Julian Baines, CEO of EKF, said:

“We are very pleased with the FDA approval of Quo-Test as this increases the portfolio of products that can now be marketed in the US.”

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