[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.5260]

[Page 219]
 
                        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. 864.5260  Automated cell-locating device.

    (a) Identification. An automated cell-locating device is a device 
used to locate blood cells on a peripheral blood smear, allowing the 
operator to identify and classify each cell according to type. 
(Peripheral blood is blood circulating in one of the body's extremities, 
such as the arm.)
    (b) Classification. Class II (performance standards).

[45 FR 60597, Sept. 12, 1980]