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MAY 24, 2013 [Diagnosis, Fasting blood glucose test] FDA allows A1c test for diagnosing diabetes
This is a Cut and Paste post from the FDA: For Immediate Release: May 23, 2013 FDA allows marketing of first A1c test labeled for diagnosing diabetes 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.