CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART I—Hematology Reagents (§864.8100 to §864.8950) > 864.8165—Calibrator for hemoglobin or hematocrit measurement.

864.8165—Calibrator for hemoglobin or hematocrit measurement.

(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.
(b) Classification. Class II (performance standards).

Code of Federal Regulations

[45 FR 60632, Sept. 12, 1980]