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Notes

§864.7695. Platelet factor 4 radioimmunoassay.

21 C.F.R. § 864.7695

(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).
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]