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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2012]
[CITE: 21CFR862.3840]
 See Related Information on 862.3840 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart D--Clinical Toxicology Test Systems

Sec. 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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