§ 864.8165. Calibrator for hemoglobin or hematocrit measurement.
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/us/cfr/t21/s§ 864.8165·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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 (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. [45 FR 60632, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]