§864.5800. Automated sedimentation rate device.
21 C.F.R. § 864.5800
Identification. An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.
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.
Notes, amendments, and revision history
Amendments
[45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]