21 C.F.R. § 864.8165 Calibrator for hemoglobin or hematocrit measurement.
Title 21 - Food and Drugs
(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). [45 FR 60632, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart I—Hematology Reagents
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
