21 CFR 864.8165 - Calibrator for hemoglobin or hematocrit measurement.

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 864: HEMATOLOGY AND PATHOLOGY DEVICES

Subpart I: Hematology Reagents

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).

[45 FR 60632, Sept. 12, 1980]

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