Vitamin D test system.

21 C.F.R. § 862.1825
in effectEffective: 2024-07-01
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(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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