21 CFR 864.5800 — Device, Automated Sedimentation Rate

Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 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 Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
GKBDevice, Automated Sedimentation Rate12
Innolitics

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