View all text of Subpart J [§ 864.9050 - § 864.9875]
§ 864.9285 - Automated cell-washing centrifuge for immuno-hematology.
(a) Identification. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.
(b) Classification. Class II (performance standards).