21 CFR 864.7695
§ 864.7695 Platelet factor 4 radioimmunoassay.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7695, § 864.7695 Platelet factor 4 radioimmunoassay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89386
- Permanent ID
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.