StacksVerified U.S. regulatory reference

21 CFR §864.5700

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II (performance standards).