21 C.F.R. § 862.1680 Testosterone test system.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§ 862.1680 Testosterone test system.
