21 CFR 864.7695 — Platelet Factor 4 Radioimmunoassay

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7695

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
LCOPlatelet Factor 4 Radioimmunoassay2133rd Party
Innolitics

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