§ 862.1825. Vitamin D test system.
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/us/cfr/t21/s§ 862.1825·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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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§ 862.1825
Vitamin D test system.
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