21 CFR 862.1090
§ 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1090, § 862.1090 Angiotensin converting enzyme (A.C.E.) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89051
- Permanent ID
ys:prov:89051@1- SHA-256
321b122ac864e1c64d0b09f81ba71f4a2844610ff0aa40e383691744fd421b1b
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Full text
(a) Identification. An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.
(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 § 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.