21 CFR 864.7360
§ 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7360, § 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89373
- Permanent ID
ys:prov:89373@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.