§864.5260. Automated cell-locating device.
21 C.F.R. § 864.5260
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.)
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60597, Sept. 12, 1980]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60597, Sept. 12, 1980]