Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart F - Automated and Semi-Automated Hematology Devices / § 864.5950 Blood volume measuring device.
§ 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).