FDA allows marketing of first A1c test labeled for diagnosing diabetes

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA allows marketing of first A1c test labeled for diagnosing diabetes

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FDA allows marketing of first A1c test labeled for diagnosing diabetes

05/23/2013 03:14 PM EDT

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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