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Code · CFR · Title 21 — Food and Drugs · Part 315 — Diagnostic Radiopharmaceuticals · § 315.2

§ 315.2. Definition.

77 words·~1 min read·/us/cfr/t21/s§ 315.2

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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.
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