866.5580—Alpha -1-lipoprotein immuno-logical test system.
               		
               	 	
               	 	
               	 	               	 	               	 	               	 	               	 	
               	 	
    
        
        (a) Identification.
         An alpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).
     
    
        
        (b) Classification.
         Class II (performance standards).