§ 864.7470. Glycosylated hemoglobin assay.
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/us/cfr/t21/s§ 864.7470·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.
(b)Classification. Class II (performance standards). [45 FR 60621, Sept. 12, 1980]