§ 866.5820. Systemic lupus erythematosus immunological test system.
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/us/cfr/t21/s§ 866.5820·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A systemic lupus erythematosus
(SLE)immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid
(DNA)or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).
(b)Classification. Class II (performance standards).