§862.1825. Vitamin D test system.
21 C.F.R. § 862.1825
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.
Notes, amendments, and revision history
Amendments
[63 FR 40366, July 29, 1998]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[63 FR 40366, July 29, 1998]