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Code of Federal Regulations Title 21. Food and Drugs § 21.862.3840 Sirolimus test system

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document:  Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.862.3840 Sirolimus test system - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-862-3840/

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