---
kind: "section"
citation: "21 C.F.R. § 862.1825"
title: "21"
number: "862.1825"
heading: "Vitamin D test system."
url: "https://uscodex.org/cfr/21/862.1825"
---

# §862.1825. Vitamin D test system.

- (a) **Identification.** A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.
- (b) **Classification.** Class II (special controls). Vitamin D test systems must comply with the following special controls:
  - (1) Labeling in conformance with [21 CFR 809.10](/cfr/21/809.10.md) and
  - (2) **Compliance with existing standards of the National Committee on Clinical Laboratory Standards.**

## Notes

### Amendments

[63 FR 40366, July 29, 1998]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[63 FR 40366, July 29, 1998]