(a) Identification.
         A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.
     
    
        
        (b) Classification.
         Class II (performance standards).
     
    
        
            Code of Federal Regulations
        
        [45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981]