21 CFR § 862.1495 - Magnesium test system.

---
identifier: "/us/cfr/t21/s862.1495"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1495 - Magnesium test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1495"
section_name: "Magnesium test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY 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 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1495 Magnesium test system.

(a) *Identification.* A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

(b) *Classification.* Class I.