21 CFR § 864.5950 Hematology and Pathology Devices

§ 864.5950 Blood volume measuring device.

Current through Sep 8, 2026 · Read all of Part 864

(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]

← § 864.5850 Automated slide spinner.§ 864.6100 Bleeding time device. →