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e-CFR data is current as of April 16, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1825


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§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 and

(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

[63 FR 40366, July 29, 1998]

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