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Electronic Code of Federal Regulations

e-CFR data is current as of March 26, 2020

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1090


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1090   Angiotensin converting enzyme (A.C.E.) test system.

(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.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]

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