21 CFR § 864.7695 - Platelet factor 4 radioimmunoassay.

---
identifier: "/us/cfr/t21/s864.7695"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7695 - Platelet factor 4 radioimmunoassay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7695"
section_name: "Platelet factor 4 radioimmunoassay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 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).

[45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. 3, 1981]