21 C.F.R. § 864.5700
Automated platelet aggregation system.
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]