21 C.F.R. § 864.5950 Blood volume measuring device.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5950 Blood volume measuring device.