CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART F—Automated and Semi-Automated Hematology Devices (§864.5200 to §864.5950) > 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).

Code of Federal Regulations

[45 FR 60603, Sept. 12, 1980]