Regulatory Text
21 C.F.R. § 862.3840 — Sirolimus test system.
§ 862.3840 Sirolimus test system. (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. [69 FR 58259, Sept. 30, 2004]
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Citation
21 C.F.R. § 862.3840
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CFR — Code of Federal Regulations
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The regulatory text of 21 C.F.R. § 862.3840 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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