CFR
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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.
Code of Federal Regulations
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