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21 CFR § 886.1670 - Ophthalmic isotope uptake probe.

---
identifier: "/us/cfr/t21/s886.1670"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.1670 - Ophthalmic isotope uptake probe."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.1670"
section_name: "Ophthalmic isotope uptake probe."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---

# 886.1670 Ophthalmic isotope uptake probe.

(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.