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e-CFR data is current as of August 12, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5660


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§866.5660   Multiple autoantibodies immunological test system.

(a) Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

(b) Classification. Class II (performance standards).

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