View all text of Subpart H [§ 864.7010 - § 864.7925]
§ 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).