21 CFR 862.1380
§ 862.1380 Hydroxybutyric dehydrogenase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1380, § 862.1380 Hydroxybutyric dehydrogenase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89120
- Permanent ID
ys:prov:89120@1- SHA-256
f1d1372617a3f06f04759495220bfff973fb948cd4da0f3887f9777531454f5f
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Full text
(a) Identification. A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.
(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.