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FDA approves HbA1c analyzer from Roche

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Roche’s cobas c 513 analyzer and HbA1c Gen. 3 assay has received clearance from the FDA, according to a company press release.

The cobas c 513 analyzer is laboratory device for measuring HbA1c that provides data for 400 patient results per hour. The analyzer features direct results, eliminating the need for manual interpretation. It also provides closed tube sampling for efficiency and safety.

The HbA1c Gen. 3 assay from Roche delivers accurate monitoring of HbA1c levels and results.

“As diabetes continues to approach epidemic proportions in the U.S. with an estimated 1.4 million American adults being diagnosed annually, the demand on health care providers and health care systems to keep up with this challenging health issue continues to increase,” said Alan Wright, MD, chief medical officer of Roche Diagnostics Corporation. “With the FDA approval of the new cobas c 513 analyzer and proven HbA1c Gen. 3 assay, Roche is now positioned to help health care organizations address the increasing need for HbA1c testing with a dedicated solution that enables them to consistently deliver confident, efficient and high-quality results.”