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FDA allows marketing of first A1c test labeled for diagnosing diabetes

May 24, 2013Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use.

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