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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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Subpart I - Hematology Reagents |
§ 864.8165 - Calibrator for hemoglobin or hematocrit measurement.
Latest version.
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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.
(b) Classification. Class II (performance standards). 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]