StacksVerified U.S. regulatory reference

21 CFR §864.5950

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.
  2. (b)Classification. Class II (performance standards).