§ 864.7360. Erythrocytic glucose-6-phosphate dehydrogenase assay.
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/us/cfr/t21/s§ 864.7360·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.
(b)Classification. Class II (performance standards). [45 FR 60616, Sept. 12, 1980]