[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR864.5950] [Page 229] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents Subpart F--Automated and Semi-Automated Hematology Devices Sec. 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]