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21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1385

17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 862.1385 — 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

§ 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system. (a) Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone ER01FE93.028 moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders. (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; 52 FR 29468, Aug. 7, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-CFR21-SEC-1A1ADF
Entity Class
REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 862.1385
Corpus
CFR — Code of Federal Regulations
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PRIMARY-SOURCE
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✓ TRUE
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1a86c05216ccb0db...
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The regulatory text of 21 C.F.R. § 862.1385 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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← 21 C.F.R. § 862.1380 21 C.F.R. § 862.1390 →
Title 21 — Food and Drugs
21 C.F.R. § 1.121 C.F.R. § 1.321 C.F.R. § 1.421 C.F.R. § 1.2021 C.F.R. § 1.2121 C.F.R. § 1.2321 C.F.R. § 1.2421 C.F.R. § 1.7021 C.F.R. § 1.7121 C.F.R. § 1.7221 C.F.R. § 1.7321 C.F.R. § 1.7421 C.F.R. § 1.7521 C.F.R. § 1.7621 C.F.R. § 1.7721 C.F.R. § 1.7821 C.F.R. § 1.7921 C.F.R. § 1.8021 C.F.R. § 1.8121 C.F.R. § 1.8321 C.F.R. § 1.9021 C.F.R. § 1.9121 C.F.R. § 1.9421 C.F.R. § 1.9521 C.F.R. § 1.9621 C.F.R. § 1.9721 C.F.R. § 1.9921 C.F.R. § 1.10121 C.F.R. § 1.22521 C.F.R. § 1.226
21 C.F.R. — public domain ← All Legislation
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