21 CFR 862.1235

§ 862.1235 Cyclosporine test system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 862.1235, § 862.1235 Cyclosporine test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89087
Permanent ID: ys:prov:89087@1
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Full text

(a) Identification. A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine. (b) Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.