21 CFR 862.1825 — System, Test, Vitamin D
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 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 Rationale
Class II (special controls). Vitamin D test systems must comply with the following special controls:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MRG | System, Test, Vitamin D | 2 | 46 | 3rd Party |
Special Controls
MRG — System, Test, Vitamin D
*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.
eCFR
MRG — System, Test, Vitamin D
(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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