21 CFR 862.1370
§ 862.1370 Human growth hormone test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1370, § 862.1370 Human growth hormone test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89116
- Permanent ID
ys:prov:89116@1- SHA-256
86c25f87b2c645ef8ec3f27b857f35cc38a739501134228d6d2ccc2f8f9d62f3
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Full text
(a) Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.
(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.