Regulatory Text
21 C.F.R. § 862.1610 — Pregnanetriol test system.
§ 862.1610 Pregnanetriol test system. (a) Identification. A pregnanetriol test system is a device intended to measure pregnanetriol (a precursor in the biosynthesis of the adrenal hormone cortisol) in urine. Measurements obtained by this device are used in the diagnosis and treatment of congenital adrenal hyperplasia (congenital enlargement of the adrenal gland). (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 2308, Jan. 14, 2000]
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-A18CE7
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 862.1610
Corpus
CFR — Code of Federal Regulations
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The regulatory text of 21 C.F.R. § 862.1610 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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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
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