§ 862.1680. Testosterone test system.
85 words·~1 min read·
/us/cfr/t21/s§ 862.1680·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
(b)Classification. Class I. [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]