CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES > SUBPART B—Clinical Chemistry Test Systems (§862.1020 to §862.1825) > 862.1825—Vitamin D test system.

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.

Code of Federal Regulations

[63 FR 40366, July 29, 1998]