[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: 21CFR864.5300]

[Page 228]
 
                        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. 864.5300  Red cell indices device.

    (a) Identification. A red cell indices device, usually part of a 
larger system, calculates or directly measures the erythrocyte mean 
corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the 
mean corpuscular hemoglobin concentration (MCHC). The red cell indices 
are used for the differential diagnosis of anemias.
    (b) Classification. Class II (performance standards).

[45 FR 60597, Sept. 12, 1980]