21 CFR 862.1825
§ 862.1825 Vitamin D test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1825, § 862.1825 Vitamin D test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89207
- Permanent ID
ys:prov:89207@1- SHA-256
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Full text
(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 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.