Code of Federal Regulations · Section
§ 892.1360 — Radionuclide Dose Calibrator
21 C.F.R. § 892.1360
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(a) Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
(b) Classification. Class II.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351