§864.5950. Blood volume measuring device.
21 C.F.R. § 864.5950
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60603, Sept. 12, 1980]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60603, Sept. 12, 1980]