21 C.F.R. § 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
