21 CFR 864.5700

§ 864.5700 Automated platelet aggregation system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 864.5700, § 864.5700 Automated platelet aggregation system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89344
Permanent ID: ys:prov:89344@1
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Full text

(a) Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma. (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.