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e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 864Subpart I → §864.8150


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart I—Hematology Reagents


§864.8150   Calibrator for cell indices.

(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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