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(a) Identification. An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.
(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.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.862.1080 Androsterone test system - last updated October 03, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-862-1080/
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