§864.7695. Platelet factor 4 radioimmunoassay.
21 C.F.R. § 864.7695
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981]