Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
All TitlesTitle 21Chapter IPart 864Subpart F - Subpart F—Automated and Semi-Automated Hematology Devices
View all text of Subpart F [§ 864.5200 - § 864.5950]
§ 864.5950 - Blood volume measuring device.

(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]
authority: 21 U.S.C. 351,360,360c,360e,360j,360
cite as: 21 CFR 864.5950
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