[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.5600]

[Page 221]
 
                        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. 864.5600  Automated hematocrit instrument.

    (a) Identification. An automated hematocrit instrument is a fully 
automated or semi-automated device which may or may not be part of a 
larger system. This device measures the packed red cell volume of a 
blood sample to distinguish normal from abnormal states, such as anemia 
and erythrocytosis (an increase in the number of red cells).
    (b) Classification. Class II (performance standards).

[45 FR 60600, Sept. 12, 1980]