[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.6400]

[Page 240]
 
                        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 G_Manual Hematology Devices
 
Sec. 864.6400  Hematocrit measuring device.

    (a) Identification. A hematocrit measuring device is a system 
consisting of instruments, tubes, racks, and a sealer and a holder. The 
device is used to measure the packed red cell volume in blood to 
determine whether the patient's total red cell volume is normal or 
abnormal. Abnormal states include anemia (an abnormally low total red 
cell volume) and erythrocytosis (an abnormally high total red cell 
mass). The packed red cell volume is produced by centrifuging a given 
volume of blood.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 864.9.

[45 FR 60606, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]