21 CFR 862.1365

§ 862.1365 Glutathione test system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 862.1365, § 862.1365 Glutathione test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89115
Permanent ID: ys:prov:89115@1
SHA-256: 48bb01a5d4714b545b2422693c070d76a00e1185b057c3e390b78d7f3920bb33

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Full text

(a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug-induced hemolytic (erythrocyte destroying) anemias due to an inherited enzyme deficiency. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.