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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1163


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1163   Cardiac allograft gene expression profiling test system.

(a) Identification. A cardiac allograft gene expression profiling test system is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern, classifier, index, score) to aid in the identification of a low probability of acute cellular rejection (ACR) in heart transplant recipients with stable allograft function.

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

[74 FR 53885, Oct. 21, 2009]

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