CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART F—Automated and Semi-Automated Hematology Devices (§864.5200 to §864.5950) > 864.5260—Automated cell-locating device.

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).

Code of Federal Regulations

[45 FR 60597, Sept. 12, 1980]