Platelet factor 4 radioimmunoassay.

21 C.F.R. § 864.7695
in effectEffective: 2024-07-01
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(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).

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