CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART G—Manual Hematology Devices (§864.6100 to §864.6700) > 864.6700—Erythrocyte sedimentation rate test.

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 § 864.9.

Code of Federal Regulations

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