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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1680


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1680   Testosterone test system.

(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]

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