21 CFR 864.7375
§ 864.7375 Glutathione reductase assay.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7375, § 864.7375 Glutathione reductase assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89374
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Full text
(a) Identification. A glutathione reductase assay is a device used to determine the activity of the enzyme glutathione reductase in serum, plasma, or erythrocytes by such techniques as fluorescence and photometry. The results of this assay are used in the diagnosis of liver disease, glutathione reductase deficiency, or riboflavin deficiency.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.