21 C.F.R. § 864.5700

Automated platelet aggregation system.

Last amended: 2016Year: 2026Length: 43 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.5700 (2026)

(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). [45 FR 60602, Sept. 12, 1980]
21 C.F.R. § 864.5700: Automated platelet aggregation system. | Justis AI