StacksVerified U.S. regulatory reference

21 CFR §862.1825

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:
    1. (1)Labeling in conformance with 21 CFR 809.10 and
    2. (2)Compliance with existing standards of the National Committee on Clinical Laboratory Standards.