{"data":{"id":"us/21-cfr-864.8165","jurisdiction":"us","citation":"21 CFR 864.8165","heading":"Calibrator for hemoglobin or hematocrit measurement.","body":"(a) Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.\n(b) Classification. Class II (special controls). The 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 I—Hematology Reagents"],"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":"e5855d044783d9440242443c0c43b0e5980dc1373c4e5888a153523ede31eb09","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.8150","next":"us/21-cfr-864.8175"},"notice":"GroundRules: Original legal text. Not legal advice."}