21 C.F.R. § 864.7695

Current through October 31, 2024
Section 864.7695 - Platelet factor 4 radioimmunoassay
(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).

21 C.F.R. §864.7695

45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981