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Trinity submits CLIA application for TRIstat HbA1c test

This article was originally published in Clinica

Executive Summary

Trinity Biotech has applied to the US FDA for a CLIA waiver for its TRIstat point-of-care HbA1c blood test. The test measures glycated haemoglobin, an indicator of diabetic patients' average blood sugar control over the past two to three months. It provides results "in minutes" and does not require refrigeration, unlike other available HbA1c tests, Bray, Ireland-based Trinity says. TRIstat received FDA 510(k) clearance in December 2007, but CLIA-waived status would mean it could be used by non-laboratory trained physicians in CLIA-certified labs.

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