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Code of Federal Regulations Title 21. Food and Drugs § 21.862.1825 Vitamin D test system

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.862.1825 Vitamin D test system - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-862-1825/

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