21 CFR 862.1678

§ 862.1678 Tacrolimus test system.

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

Cite this

Citation: 21 CFR 862.1678, § 862.1678 Tacrolimus test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89185
Permanent ID: ys:prov:89185@1
SHA-256: b27702b0000fbc6e60d5db5acdc6302d91f37d53735999ff0c35c66d2284ad89

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(a) Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus 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 tacrolimus. (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.