Blood volume measuring device.
21 C.F.R. § 864.5950
in effectEffective: 2024-07-01(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).
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
