21 CFR 862.1495 — Electrode, Ion Specific, Magnesium
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1495
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).
Classification Rationale
Class I.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CFA | Electrode, Ion Specific, Magnesium | 1 | 2 | 3rd Party |
| CFO | Titrimetric, Magnesium | 1 | 0 | 3rd Party |
| JGI | Atomic Absorption, Magnesium | 1 | 0 | 3rd Party |
| JGJ | Photometric Method, Magnesium | 1 | 90 | 3rd Party |
