[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: 21CFR864.6700]

[Page 223]
 
                        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. 864.6700  Erythrocyte sedimentation rate test.

    (a) Identification. An erythrocyte sedimentation rate test is a 
device that measures the length of time required for the red cells in a 
blood sample to fall a specified distance or a device that measures the 
degree of sedimentation taking place in a given length of time. An 
increased rate indicates tissue damage or inflammation.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9.

[45 FR 60608, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38790, July 25, 2001]

[[Page 224]]