21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1625

Prolactin (lactogen) test system.

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Regulatory Text

21 C.F.R. § 862.1625 — Prolactin (lactogen) test system.

§ 862.1625 Prolactin (lactogen) test system. (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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

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21 C.F.R. § 862.1625
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The regulatory text of 21 C.F.R. § 862.1625 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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