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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, 2013]
[CITE: 21CFR862.1678]
See Related Information on Tacrolimus test system. 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 B--Clinical Chemistry Test Systems

Sec. 862.1678 Tacrolimus test system.

(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.

[67 FR 58329, Sept. 16, 2002]

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