21 CFR 892.1360 — Calibrator, Dose, Radionuclide
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1360
Identification
A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | 2 | 32 | 3rd Party |