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e-CFR data is current as of July 9, 2020

Title 21Chapter ISubchapter HPart 866Subpart E → §866.4070


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart E—Immunology Laboratory Equipment and Reagents


§866.4070   RNA Preanalytical Systems.

(a) Identification. RNA Preanalytical Systems are devices intended to collect, store, and transport patient specimens, and stabilize intracellular RNA from the specimens, for subsequent isolation and purification of the intracellular RNA for RT-PCR used in in vitro molecular diagnostic testing.

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification System for RT-PCR Used in Molecular Diagnostic Testing).” See §866.1(e) for the availability of this guidance document.

[70 FR 49863, Aug. 25, 2005]

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