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e-CFR data is current as of October 22, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5260


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices


§864.5260   Automated cell-locating device.

(a) Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

(b) Classification. Class II (performance standards).

[45 FR 60597, Sept. 12, 1980]

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