21 CFR 862.1535
§ 862.1535 Ornithine carbamyl transferase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1535, § 862.1535 Ornithine carbamyl transferase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89152
- Permanent ID
ys:prov:89152@1- SHA-256
1f885ff85d656a8a83543ef7faa2d47e16cba6e771e58d3e644f148f7e6f3572
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. An ornithine carbamyl transferase test system is a device intended to measure the activity of the enzyme ornithine carbamyl transferase (OCT) in serum. Ornithine carbamyl transferase measurements are used in the diagnosis and treatment of liver diseases, such as infectious hepatitis, acute cholecystitis (inflammation of the gall bladder), cirrhosis, and liver metastases.
(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 § 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.