{"data":{"id":"us/21-cfr-864.6700","jurisdiction":"us","citation":"21 CFR 864.6700","heading":"Erythrocyte sedimentation rate test.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart G—Manual Hematology Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"6381fc653004e6a88fd11efa3c40234331ffff4556d5fce13f299496f49fabc7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.6675","next":"us/21-cfr-864.7010"},"notice":"GroundRules: Original legal text. Not legal advice."}