[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: 21CFR864.5200]

[Page 227]
 
                        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. 864.5200  Automated cell counter.


    (a) Identification. An automated cell counter is a fully-automated 
or semi-automated device used to count red blood cells, white blood 
cells, or blood platelets using a sample of the patient's peripheral 
blood (blood circulating in one of the body's extremities, such as the 
arm). These devices may also measure hemoglobin or hematocrit and may 
also calculate or measure one or more of the red cell indices (the 
erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or 
the mean corpuscular hemoglobin concentration). These devices may use 
either an electronic particle counting method or an optical counting 
method.
    (b) Classification. Class II (performance standards).

[45 FR 60593, Sept. 12, 1980]