862.1225—Creatinine test system.
               		
               	 	
               	 	
               	 	               	 	               	 	               	 	               	 	
               	 	
    
        
        (a) Identification.
         A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
     
    
        
        (b) Classification.
         Class II.