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Code · CFR · Title 21 — Food and Drugs · Part 864 — Hematology and Pathology Devices · § 864.8150

§ 864.8150. Calibrator for cell indices.

114 words·~1 min read·/us/cfr/t21/s§ 864.8150·

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(a)Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other 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 60631, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]
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