{"data":{"id":"us/21-cfr-864.6600","jurisdiction":"us","citation":"21 CFR 864.6600","heading":"Osmotic fragility test.","body":"(a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.\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":"2af6a614f41ed8272a93f3da3593f94cbe22fe28a89fe66fb01fca0cb3ee2d0a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.6550","next":"us/21-cfr-864.6650"},"notice":"GroundRules: Original legal text. Not legal advice."}