CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART H—Hematology Kits and Packages (§864.7040 to §864.7925) > 864.7695—Platelet factor 4 radioimmunoassay.

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).

Code of Federal Regulations

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