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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 862: CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B: Clinical Chemistry Test Systems
862.1245 - Dehydroepiandrosterone (free and sulfate) test system.
(a) Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
(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 2306, Jan. 14, 2000]
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