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Code · CFR · Title 21 — Food and Drugs · Part 601 — Licensing · § 601.31

§ 601.31. Definition.

76 words·~1 min read·/us/cfr/t21/s§ 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.
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§ 601.31
Definition.
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