Code of Federal Regulations · Section

§ 601.31 — Definition

21 C.F.R. § 601.31

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For purposes of this part,diagnostic radiopharmaceutical means:

(a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or

(b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in paragraph (a) of this section.

21 C.F.R. § 601.30 21 C.F.R. § 601.32

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