---
kind: "section"
citation: "21 C.F.R. § 864.7695"
title: "21"
number: "864.7695"
heading: "Platelet factor 4 radioimmunoassay."
url: "https://uscodex.org/cfr/21/864.7695"
---

# §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).

## Notes

### 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]