21 CFR 886.1670 — Probe And Counter, Isotope, For Phosphorus 32
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1670
Identification
An ophthalmic isotope uptake probe is an AC-powered device intended to measure, by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HPW | Probe And Counter, Isotope, For Phosphorus 32 | 2 | 0 | 3rd Party |
