Electronic Code of Federal Regulations
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e-CFR data is current as of February 24, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1678 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§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]