(a) Identification.
         An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.
     
    
        
        (b) Classification.
         Class II (performance standards).
     
    
        
            Code of Federal Regulations
        
        [45 FR 60618, Sept. 12, 1980]