21 CFR 862.1565
§ 862.1565 6-Phosphogluconate dehydrogenase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1565, § 862.1565 6-Phosphogluconate dehydrogenase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89159
- Permanent ID
ys:prov:89159@1- SHA-256
70b8a1e539ab213a2da4f883ec2b95061e5beeaca6a2db603448683e20a1da7f
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A 6-phosphogluconate dehydrogenase test system is a device intended to measure the activity of the enzyme 6-phosphogluconate dehydrogenase (6 PGD) in serum and erythrocytes. Measurements of 6-phosphogluconate dehydrogenase are used in the diagnosis and treatment of certain liver diseases (such as hepatitis) and anemias.
(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.