21 CFR 862.1625
§ 862.1625 Prolactin (lactogen) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1625, § 862.1625 Prolactin (lactogen) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89173
- Permanent ID
ys:prov:89173@1- SHA-256
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Full text
(a) Identification. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
(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.