866.5820—Systemic lupus erythema-tosus immunological test system.
               		
               	 	
               	 	
               	 	               	 	               	 	               	 	               	 	
               	 	
    
        
        (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).