(a) Identification.
         A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.
     
    
        
        (b) Classification.
         Class II (performance standards).
     
    
        
            Code of Federal Regulations
        
        [45 FR 60603, Sept. 12, 1980]