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.
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:
Labeling in conformance with 21 CFR 809.10 and
Compliance with existing standards of the National Committee on Clinical Laboratory Standards.
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