21 C.F.R. § 864.5950
Blood volume measuring device.
Cite as 21 C.F.R. § 864.5950 (2026)
(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. (b) Classification. Class II (performance standards). [45 FR 60603, Sept. 12, 1980]