Code of Federal Regulations · Section
§ 886.1670 — Ophthalmic Isotope Uptake Probe
21 C.F.R. § 886.1670
View:
(a) 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.
(b) Classification. Class II.
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351