21 CFR 864.6700 — Tube, Sedimentation Rate
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6700
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.
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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GHC | Tube, Sedimentation Rate | 1 | 1 | |
| JPH | Test, Erythrocyte Sedimentation Rate | 1 | 7 |
