StacksVerified U.S. regulatory reference

21 CFR §864.9285

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.
  2. (b)Classification. Class II (performance standards).