21 CFR § 864.5260 Hematology and Pathology Devices

§ 864.5260 Automated cell-locating device.

Current through Sep 8, 2026 · Read all of Part 864

(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]

← § 864.5240 Automated blood cell diluting apparatus.§ 864.5300 Red cell indices device. →